Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- DZSCapsule, Dental, Amalgam1Product Code
- DYHAdhesive, Bracket And Tooth Conditioner, Resin2Product Code
- DZEImplant, Endosseous, Root-Form2Product Code
- K242072CeraRoot TL Implant System (TL)2Cleared 510(K)
- K233271OsseOne Dental Implant System2Cleared 510(K)
- K250176DAND Dental Implant System2Cleared 510(K)
- K241703SD Implant System2Cleared 510(K)
- K241462LONGY Implant and LONGY-N Implant2Cleared 510(K)
- K242217Surcam Dental Implant System2Cleared 510(K)
- K242661TRI-matrix® X-Force Implants2Cleared 510(K)
- K242753SD TL Implant System2Cleared 510(K)
- K241972BLUEDIAMOND IMPLANT2Cleared 510(K)
- K241127INNO SLA Mini Plus® Implant System2Cleared 510(K)
- K240435Alpha Dent Implants Dental Implants System2Cleared 510(K)
- K243094Quickdent Dental Implant System2Cleared 510(K)
- K243066Dental Implants and Abutments2Cleared 510(K)
- K241391Straumann® PURE Ceramic Implants2Cleared 510(K)
- K241692MIS LYNX Conical Connection Implant System2Cleared 510(K)
- K233081NUVENTUS NV.C™ Dental Implant System2Cleared 510(K)
- K242379LL Implant System2Cleared 510(K)
- K242261Accelx Implant System2Cleared 510(K)
- K240383Highness Implant System2Cleared 510(K)
- K240560ZENEX Implant System_Long2Cleared 510(K)
- K241753Immediate Molar Implants2Cleared 510(K)
- K240143JDZygoma dental implants2Cleared 510(K)
- K240262BTI Interna 3.0 Dental Implant System UnicCa®2Cleared 510(K)
- K240977DenQ Sub SLA Implant System2Cleared 510(K)
- K240232EK D3.3 and Ultra Wide Implants2Cleared 510(K)
- K240803Surgikor Fixation One, Abutment Blanks and Abutments2Cleared 510(K)
- K231566ICX-Implant System2Cleared 510(K)
- K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw2Cleared 510(K)
- K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus2Cleared 510(K)
- K240837TOV Dental Implant System2Cleared 510(K)
- K233808LW Narrow Implant System2Cleared 510(K)
- K240609S.I.N. Dental Implant System2Cleared 510(K)
- K240966Prima Plus Conical Implant System2Cleared 510(K)
- K240202Conical Platform Dental Implants System2Cleared 510(K)
- K240187Tapered Pro Conical Implant System2Cleared 510(K)
- K232821S.I.N. Dental Implant System2Cleared 510(K)
- K2314268plant Implant System2Cleared 510(K)
- K232740Paltop Short Implants2Cleared 510(K)
- K240511Dentis s-Clean SQ-SL Fixture2Cleared 510(K)
- K233137Ticare Dental Implant Systems2Cleared 510(K)
- K233231Dental Implants and Abutments2Cleared 510(K)
- K240091NB Mini Implant System2Cleared 510(K)
- K221847Ni2 Implant System2Cleared 510(K)
- K232726External Hex Implant System2Cleared 510(K)
- K232049IS-III active Short Implant2Cleared 510(K)
- K232268STERI-OSS Implant System2Cleared 510(K)
- K234049Straumann® BLC and TLC Implants - Line extension2Cleared 510(K)
- K221866S-Plant Dental Implant System2Cleared 510(K)
- K230438URIS Smart Path Implant System & Prosthetic2Cleared 510(K)
- K223714UniFit Dental Implant System2Cleared 510(K)
- K233163ZENEX Implant System_Short2Cleared 510(K)
- K231429S-Plant Dental Implant System2Cleared 510(K)
- K231967ARi ExCon Implant System2Cleared 510(K)
- K231127S.I.N. Dental Implant System2Cleared 510(K)
- K232418Single Platform SP1 Implant System2Cleared 510(K)
- K232099Neodent Implant System - GM Zygomatic Implant System2Cleared 510(K)
- K221315UNIdental Symphony Implant System2Cleared 510(K)
- K231395INNO SLA Submerged Narrow Implant System2Cleared 510(K)
- K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL2Cleared 510(K)
- K223697MRI compatibility for existing BioHorizons dental implants and abutments2Cleared 510(K)
- K230618MegaGen Dental Implant Systems Portfolio - MR Conditional2Cleared 510(K)
- K230242OsteoCentric Dental Implant System2Cleared 510(K)
- K222778Osstem Implant System2Cleared 510(K)
- K230108Straumann® BLC and TLC Implants2Cleared 510(K)
- K222946Oneday Mini Implant System2Cleared 510(K)
- K223924LW Implant System2Cleared 510(K)
- K230630ZENEX Implant System_Narrow2Cleared 510(K)
- K223339Bone Chamber Implant2Cleared 510(K)
- K222707IH Implant System2Cleared 510(K)
- K230725NB Implant System2Cleared 510(K)
- K221488Z7 Zirconia Implant System2Cleared 510(K)
- K222142BR SLA Type Implant System2Cleared 510(K)
- K223638Neodent Implant System - Helix Short Implant System2Cleared 510(K)
- K223083Straumann SLActive labeling changes2Cleared 510(K)
- K222144IR SLA Type Implant System2Cleared 510(K)
- K222792SNUCONE Tissue Level Implant System2Cleared 510(K)
- K221752Stella2Cleared 510(K)
- K223814Genesis ACTIVE Implant System2Cleared 510(K)
- K222738Point implant system2Cleared 510(K)
- K222457Provata Implant System2Cleared 510(K)
- K222211Implant Direct Dental Implant Systems Portfolio - MR Conditional2Cleared 510(K)
- K221317S-Mono2Cleared 510(K)
- K211812BLUEDIAMOND IMPLANT, Abutment Screw2Cleared 510(K)
- K220517IBS System2Cleared 510(K)
- K213677Bonafix 2 Plus2Cleared 510(K)
- K221453S.I.N. Dental Implant System2Cleared 510(K)
- K221910QRS Dental Implants System2Cleared 510(K)
- K220079Magicore Narrow System2Cleared 510(K)
- K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connection2Cleared 510(K)
- K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)2Cleared 510(K)
- K222497Zaga Zygomatic System2Cleared 510(K)
- K222231S.I.N. Dental Implant System2Cleared 510(K)
- K211409Proximerge 2 Dental Implant System2Cleared 510(K)
- K212702IM/ST Fixture System2Cleared 510(K)
- K222131NB 1 SA Implant System2Cleared 510(K)
- K220978TSX Implants2Cleared 510(K)
- K220251Neodent Implant System - GM Narrow Implant System2Cleared 510(K)
- K212364BLT Dental Implant System2Cleared 510(K)
- K211952BTI Interna Narrow/Plus Dental Implant System UnicCa2Cleared 510(K)
- K213997Kontact Dental Implant System2Cleared 510(K)
- K213576Tatum Surgical Dental Implant System2Cleared 510(K)
- K210354SNUCONE Bone Level Implant System2Cleared 510(K)
- K212775Adin Short Implants2Cleared 510(K)
- K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments2Cleared 510(K)
- K210852Noris Medical Dental Implants System - Cortical2Cleared 510(K)
- K220200Paltop Conical Implant System2Cleared 510(K)
- K211090ZENEX Implant System2Cleared 510(K)
- K213506NB 1 SA Implant System2Cleared 510(K)
- K220022TRATE Dental Implant System2Cleared 510(K)
- K213672T3 Pro Implants2Cleared 510(K)
- K210489SICtapered & SICvantage tapered2Cleared 510(K)
- K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant System2Cleared 510(K)
- K213599SuperLine2Cleared 510(K)
- K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants2Cleared 510(K)
- K210039CORE1 Implant System2Cleared 510(K)
- K203360EK Implants and Abutments System2Cleared 510(K)
- K211978Jplant2Cleared 510(K)
- K211109N1 TiUltra TCC Implant System2Cleared 510(K)
- K203660TRI-matrix Implant Line2Cleared 510(K)
- K212538DESS Dental Implants2Cleared 510(K)
- K210117Paltop Narrow Implant2Cleared 510(K)
- K210499Alpha Dent Implants Dental Implants System2Cleared 510(K)
- K211921S.I.N. Dental Implant System2Cleared 510(K)
- K212517Magicore System2Cleared 510(K)
- K210523Implanova2Cleared 510(K)
- K212125Nobel Biocare Dental Implant Systems Portfolio - MR Conditional2Cleared 510(K)
- K202092ABC Dental Implant System2Cleared 510(K)
- K203554AnyOne External Implant System2Cleared 510(K)
- K210610PrimeTaper EV Dental Implant2Cleared 510(K)
- K210336Neodent Implant System - Zirconia Implant System2Cleared 510(K)
- K202825BTI Extra-Short Dental Implant System UnicCa2Cleared 510(K)
- K211052Straumann RidgeFit Implants2Cleared 510(K)
- K203309NUVO CF Implant System2Cleared 510(K)
- K203725S.I.N. Dental Implant System2Cleared 510(K)
- K210161AnyOne Onestage Implant System2Cleared 510(K)
- K210855Straumann BLX Implant System2Cleared 510(K)
- K210220Kontact Dental Implant System2Cleared 510(K)
- K210886MIS Lance+ Conical Connection Dental Implant System2Cleared 510(K)
- K210080Dentis s-Clean s-Line Mini2Cleared 510(K)
- K202832Implacil Implant System2Cleared 510(K)
- K200573BoneTrust Mini Implant System2Cleared 510(K)
- K200329IDCAM Dental Implants2Cleared 510(K)
- K210134Dentis s-Clean s-Line2Cleared 510(K)
- K203701Locator Overdenture Implant System2Cleared 510(K)
- K202773s-Clean SQ-SL Implant System Mini2Cleared 510(K)
- K203382Neodent Implant System-Easy Pack2Cleared 510(K)
- K210132s-Clean SQ-SL Implant System Regular2Cleared 510(K)
- K192839DSP Implant System2Cleared 510(K)
- K202942Straumann 4 mm Short Implants2Cleared 510(K)
- K201553Simply Iconic Implants2Cleared 510(K)
- K201700BEGO Semados® RS/RSX Implant System2Cleared 510(K)
- K201491Neodent Implant System - Zirconia Implant System2Cleared 510(K)
- K201712Z5-TL2Cleared 510(K)
- K200992S.I.N. Dental Implant System2Cleared 510(K)
- K202344TiUltra Implants and Xeal Abutments2Cleared 510(K)
- K183044JTK Dental Implant System2Cleared 510(K)
- K181477MS Lide Implant Systems2Cleared 510(K)
- K200906MINICONE Implant2Cleared 510(K)
- K200386Z5-BL2Cleared 510(K)
- K200817URIS OMNI Narrow System & Prosthetic2Cleared 510(K)
- K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants2Cleared 510(K)
- K202039Honorst Implant System2Cleared 510(K)
- K202479IBS Implant System2Cleared 510(K)
- K201225Neodent Implant System - GM Helix Implants 7.02Cleared 510(K)
- K200102MIS Dental Implant System2Cleared 510(K)
- K201981Magicore System2Cleared 510(K)
- K192062Nucleoss T6 Dental Implant System2Cleared 510(K)
- K200586Straumann TLX Implant System2Cleared 510(K)
- K201334Keystone Dental XL Dental Implant System2Cleared 510(K)
- K192294I Do2Cleared 510(K)
- K191443MSDI Dental Implants System2Cleared 510(K)
- K182081JDentalCare Implant System JDIcon2Cleared 510(K)
- K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts2Cleared 510(K)
- K190637Fit & Brilliant Dental Implant System2Cleared 510(K)
- K193234NUVO IF Implant System2Cleared 510(K)
- K192274BV Dental Implant System2Cleared 510(K)
- K193096S.I.N. Dental Implant System2Cleared 510(K)
- K192651ZAGA Zygomatic System2Cleared 510(K)
- K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment System2Cleared 510(K)
- K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants2Cleared 510(K)
- K192197Magicore II System2Cleared 510(K)
- K200099s-Clean SQ-SL Implant System Mini2Cleared 510(K)
- K192015Faico Dental Implant System2Cleared 510(K)
- K200188DSI Dental Implant System2Cleared 510(K)
- K190919ST Internal Implant System2Cleared 510(K)
- K190641AR_N SLA Type Implant System2Cleared 510(K)
- K190406SDS2.2 dental implant2Cleared 510(K)
- K183024Implacil Implant System2Cleared 510(K)
- K190192K3Pro Konus New Abutments and Implants2Cleared 510(K)
- K192688s-Clean SQ-SL Implant System Regular2Cleared 510(K)
- K190837Internal Hex Implant System2Cleared 510(K)
- K190243Z5-BL2Cleared 510(K)
- K191256Straumann BLX Ø3.5 mm Implants2Cleared 510(K)
- K191751EM Provisional2Cleared 510(K)
- K192149MIS Dental Implant System2Cleared 510(K)
- K191895Straumann Mini Implants2Cleared 510(K)
- K191054Southern Implants MAX Implant System2Cleared 510(K)
- K190552JJ Implant System2Cleared 510(K)
- K181953SDS1.2 dental implant2Cleared 510(K)
- K191201EM SA Implant System2Cleared 510(K)
- K192347ST Internal Implant System2Cleared 510(K)
- K190958Neodent Implant System2Cleared 510(K)
- K192053W Zirconia Implants2Cleared 510(K)
- K182448AnyRidge Octa 1 Implant System2Cleared 510(K)
- K191127Advanced Intermezzo Implant System2Cleared 510(K)
- K182143ALFA GATE Dental Implants System2Cleared 510(K)
- K182219SGS Dental Implants System2Cleared 510(K)
- K190849IS-III active System_S-narrow Type2Cleared 510(K)
- K182908Ziacom Dental Implant Systems2Cleared 510(K)
- K190718Zygomatic Implants2Cleared 510(K)
- K182615Surgikor Dental Implant System2Cleared 510(K)
- K180365PRAMA White Implant Systems2Cleared 510(K)
- K180968AlphaDent Implants Dental Implants System2Cleared 510(K)
- K190662MRI Compatibility for Existing Straumann Dental Implant Systems2Cleared 510(K)
- K181157Conical Plus Implant System2Cleared 510(K)
- K183242ET IV SA Dental Implants2Cleared 510(K)
- K180924Reflect Implant System2Cleared 510(K)
- K182313BoneTrust Implant System2Cleared 510(K)
- K173418NobelParallel Conical Connection2Cleared 510(K)
- K182293OsseOne Dental Implant System2Cleared 510(K)
- K180183Ritter Dental Implant System2Cleared 510(K)
- K182620MRI Compatibility for Existing Neodent Implant System2Cleared 510(K)
- K180477Straumann PURE Ceramic Implant System2Cleared 510(K)
- K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments2Cleared 510(K)
- K182194UV Active Implant System2Cleared 510(K)
- K180859PYRAMIDION Dental Implants and Prostheses2Cleared 510(K)
- K183069NobelZygoma 0°2Cleared 510(K)
- K173701Implant-One System2Cleared 510(K)
- K181137IT-III active System2Cleared 510(K)
- K181850Inversa Implants2Cleared 510(K)
- K172668W Zirconia Implants2Cleared 510(K)
- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment System2Cleared 510(K)
- K170732Biomate Dental Implant System2Cleared 510(K)
- K182070BioHorizons Tapered IM Implants2Cleared 510(K)
- K181138IS-III active System2Cleared 510(K)
- K173141CSM Submerged3-L Implant System2Cleared 510(K)
- K180465Provata Implant System2Cleared 510(K)
- K180536Neodent Implant System – GM Line2Cleared 510(K)
- K173575OsteoReady Dental Implant System2Cleared 510(K)
- K173257BTI Dental Implant System UnicCa2Cleared 510(K)
- K173819MyPlant II Implant System2Cleared 510(K)
- K180598UNIQA Dental Implants System2Cleared 510(K)
- K181178S-mini active Fixture2Cleared 510(K)
- K171197Zuga Dental Implant System2Cleared 510(K)
- K173116KJ ZIRCONIA Implant System2Cleared 510(K)
- K180282MIS Internal Hex Dental Implant System2Cleared 510(K)
- K172345IU Implant System2Cleared 510(K)
- K172821Ti-one 101 TS Dental Implant System2Cleared 510(K)
- K173706Piccolo Implants and Accessories2Cleared 510(K)
- K173961Straumann BLX Implant System2Cleared 510(K)
- K173975UF(II) Wide Fixture2Cleared 510(K)
- K173938IS-III HActive Fixture2Cleared 510(K)
- K180360OKTAGON Implant System2Cleared 510(K)
- K172100URIS OMNI System2Cleared 510(K)
- K170776DTI-1 SLA IMPLANT SYSTEM2Cleared 510(K)
- K173207SIC invent Dental Implant Systems2Cleared 510(K)
- K172630Kisses Plus Implant System2Cleared 510(K)
- K170608UF(II) Implant System2Cleared 510(K)
- K173343Zygomatic Implant System2Cleared 510(K)
- K170131TAV Medical Dental Implants System2Cleared 510(K)
- K171179BR Type Implant System2Cleared 510(K)
- K172240SPI Dental Implant System2Cleared 510(K)
- K171297AR_N Type Implant System2Cleared 510(K)
- K171784Straumann Dental Implant System2Cleared 510(K)
- K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments2Cleared 510(K)
- K172560PREMIUM ONE Implant Systems2Cleared 510(K)
- K171185IR Type Implant System2Cleared 510(K)
- K170392S.I.N. Implant System2Cleared 510(K)
- K172576BioHorizons Tapered Short Implants2Cleared 510(K)
- K170398S.I.N. Dental Implant System2Cleared 510(K)
- K171769Straumann PURE Ceramic Implants2Cleared 510(K)
- K161923J2A SLA Dental Implant System2Cleared 510(K)
- K163634External Hex Implants2Cleared 510(K)
- K172352TREFOIL System2Cleared 510(K)
- K170394Kisses Mini2Cleared 510(K)
- K171795Thommen Implant System2Cleared 510(K)
- K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm2Cleared 510(K)
- K162482A.B. DENTAL DEVICES Dental Implants System2Cleared 510(K)
- K171126Implantium II2Cleared 510(K)
- K171027Dentis Dental Implant System2Cleared 510(K)
- K170031Internal Octa Implant System2Cleared 510(K)
- K163385Cortex Dental Implant System2Cleared 510(K)
- K160850Nucleoss Tpure Implant System2Cleared 510(K)
- K162867MagDen Dental Implant System2Cleared 510(K)
- K163194Neodent Implant System - GM Line2Cleared 510(K)
- K162853Bonafix TWO - Dental Implant System2Cleared 510(K)
- K170372SpiralTech Dental Implant System2Cleared 510(K)
- K162299Spiral Shape Dental Implant System2Cleared 510(K)
- K161177Axiom PX2Cleared 510(K)
- K163060Deep Conical (DC) Implants and Accessories2Cleared 510(K)
- K163349MIS V3 Conical Connection Dental Implant System2Cleared 510(K)
- K170287Dental Implants OKTAGON Bone Level Tapered Design2Cleared 510(K)
- K160398MRI Compatibility for Existing Zimmer Dental Implant Systems2Cleared 510(K)
- K163557SS SA Fixture2Cleared 510(K)
- K170135TREFOIL System2Cleared 510(K)
- K163640QZA and RS Dental Implant Systems2Cleared 510(K)
- K170220OneQ-SL s-Clean Implant System2Cleared 510(K)
- K170211Insight Dental System2Cleared 510(K)
- K163088TSIII BA Fixture2Cleared 510(K)
- K161743Etgar Dental Implant System2Cleared 510(K)
- K160581K3PRO Konus Additional Abutments and Implants2Cleared 510(K)
- K162308Noris Medical MBI-2mm Dental Implant System2Cleared 510(K)
- K161598NobelZygoma 0°2Cleared 510(K)
- K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment2Cleared 510(K)
- K162073Dental Implants OKTAGON Tissue Level and Bone Level2Cleared 510(K)
- K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure2Cleared 510(K)
- K162099IBS Implant System II2Cleared 510(K)
- K161103US SA Implant System2Cleared 510(K)
- K161593GMI Frontier Dental Implant System2Cleared 510(K)
- K160965SuperLine2Cleared 510(K)
- K161281Dentalis Bio Solution Implants2Cleared 510(K)
- K160536Chaorum Implant System2Cleared 510(K)
- K160475Ritter Dental Implant System2Cleared 510(K)
- K161244s-Clean OneQ-SL Narrow Implant System2Cleared 510(K)
- K163043Zeramex P6 Dental Implant System2Cleared 510(K)
- K161497Dental Implants and Abutments2Cleared 510(K)
- K153332ETIII SA Fixture System (O3.2mm)2Cleared 510(K)
- K151970KJ Mini Implant System2Cleared 510(K)
- K161604OSSTEM Implant System2Cleared 510(K)
- K153521IH Implant System2Cleared 510(K)
- K160060DMi Dental Implant System2Cleared 510(K)
- K160221Implance Dental Implant System, Implance Dental Abutment System2Cleared 510(K)
- K142846BBX1, BBX2, BBX1MO, BBX1MC2Cleared 510(K)
- K160106LUNA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K151757IMMEDIATELOAD Dental Implant System2Cleared 510(K)
- K152385Zeramex P6 Dental Implant System2Cleared 510(K)
- K152787ST Internal Fixture System2Cleared 510(K)
- K151626ET III Bio-SA Fixture System2Cleared 510(K)
- K153268NR Line Implant System2Cleared 510(K)
- K160213s-Clean Tapered II RBM Implant System2Cleared 510(K)
- K152786A Plus Internal Fixture System2Cleared 510(K)
- K160119NobelSpeedy Groovy2Cleared 510(K)
- K152576Anker II Dental Implant System2Cleared 510(K)
- K153099INCLUSIVE TAPERED IMPLANT SYSTEM2Cleared 510(K)
- K153650Microdent Ektos Implant System2Cleared 510(K)
- K153350IBS Implant System2Cleared 510(K)
- K153111TOUAREG CloseFit™ UNP 2.75mmD2Cleared 510(K)
- K151391BTI Dental Implant System UnicCa2Cleared 510(K)
- K153064Blue Sky Bio Zygomatic Implant System2Cleared 510(K)
- K151588maxFit II Dental Implant System2Cleared 510(K)
- K153043Noris Medical MBI Dental Implant System2Cleared 510(K)
- K152836TREFOIL System2Cleared 510(K)
- K153639OneQ-SL s-Clean Implant System2Cleared 510(K)
- K153098KLOCKNER VEGA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K151909Noris Medical Zygomatic Dental Implant System2Cleared 510(K)
- K153758Straumann Bone Level Tapered Implants2Cleared 510(K)
- K152093NobelZygoma 45°2Cleared 510(K)
- K152555Dental Implant System2Cleared 510(K)
- K153173MOR Implant System2Cleared 510(K)
- K152188QUAD Dental Implants and Prostheses2Cleared 510(K)
- K152520Magicore System2Cleared 510(K)
- K151328PURE Ceramic Implants2Cleared 510(K)
- K151916TRI Dental Implant System2Cleared 510(K)
- K142313OneQ-SL Implant System2Cleared 510(K)
- K1505713i T3 Short Implants2Cleared 510(K)
- K150388Dental Implant System2Cleared 510(K)
- K151928PUR Dental Implant System2Cleared 510(K)
- K143142JDENTALCARE Implant System2Cleared 510(K)
- K151599iSy Implant System2Cleared 510(K)
- K142557Anker Dental Implant System - SB-III, ST and AT series2Cleared 510(K)
- K143539Dental Implant OKTAGON Bone Level2Cleared 510(K)
- K150040Implanova2Cleared 510(K)
- K143758PerioType Rapid2Cleared 510(K)
- K150021Z5m(t)2Cleared 510(K)
- K142813Biogensis Implant System-Kisses2Cleared 510(K)
- K150968TRU Dental Implant System2Cleared 510(K)
- K150938Straumann® Dental Implant System ¿ Roxolid® SLA Implants2Cleared 510(K)
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- K150537MiNi Internal Implant System2Cleared 510(K)
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- K1430112014 InterActive/SwishActive System2Cleared 510(K)
- K150363NOVA Dental Implants System2Cleared 510(K)
- K150199Neodent Implant System2Cleared 510(K)
- K142751Chang Gung ComMed Series Dental Implant System2Cleared 510(K)
- K141188MICRODENT GENIUS IMPLANT SYSTEM2Cleared 510(K)
- K143326T.A.G. Dental Implant System2Cleared 510(K)
- K142260NobelActive2Cleared 510(K)
- K150182Neodent Implant System- CM Drive Implants2Cleared 510(K)
- K150060J2A Dental Implant System, J2C Dental Implant System2Cleared 510(K)
- K143353Hahn Tapered Implant System2Cleared 510(K)
- K142426EBI External Implant System2Cleared 510(K)
- K140806IBS IMPLANT SYSTEM2Cleared 510(K)
- K142174BIOMATE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K141159KONUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K142242PREMIUM, SHELTA Implant Systems2Cleared 510(K)
- K133733WINSIX Implant System2Cleared 510(K)
- K143022BioHorizons Tapered Internal Implants2Cleared 510(K)
- K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm2Cleared 510(K)
- K140440NORIS MEDICAL DENTAL IMPLANTS SYSTEM2Cleared 510(K)
- K140202TRAUSIM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K140091XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM2Cleared 510(K)
- K133362SGS DENTAL IMPLANT2Cleared 510(K)
- K140934HIOSSEN IMPLANT SYSTEM2Cleared 510(K)
- K140293TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM2Cleared 510(K)
- K140052J2I IMPLANT SYSTEM2Cleared 510(K)
- K140051KJ EXTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K142082ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT2Cleared 510(K)
- K140728MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR2Cleared 510(K)
- K133050ONE PLUS IMPLANT SYSTEM2Cleared 510(K)
- K141450AXIOM 2.82Cleared 510(K)
- K133592NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM2Cleared 510(K)
- K133706ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM2Cleared 510(K)
- K140878STRAUMANN BONE LEVEL TAPERED IMPLANT2Cleared 510(K)
- K140347ANKYLOS C/X IMPLANT SYSTEM2Cleared 510(K)
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- K133991ISY2Cleared 510(K)
- K132881Z5C2Cleared 510(K)
- K133327SATURNO(TM) OVERDENTURE IMPLANT SYSTEM2Cleared 510(K)
- K130694JR IMPLANT SYSTEM2Cleared 510(K)
- K133884BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM2Cleared 510(K)
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- K132956U FIT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K132585ZIBONE CERAMIC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K131557RITTER IMPLANT SYSTEM2Cleared 510(K)
- K133731NOBELACTIVE WIDE PLATFORM (WP)2Cleared 510(K)
- K132178MOSTDI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K132144KERATOR2Cleared 510(K)
- K133613INTRA-LOCK DENTAL IMPLANTS2Cleared 510(K)
- K131258SATURN DENTAL IMPLANT2Cleared 510(K)
- K133339ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED2Cleared 510(K)
- K133510NEODENT IMPLANT SYSTEM2Cleared 510(K)
- K131066AXIOM REG2Cleared 510(K)
- K132125A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM2Cleared 510(K)
- K1330493I T3(R) EXTERNAL HEX DENTAL IMPLANTS2Cleared 510(K)
- K130572INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM2Cleared 510(K)
- K132992TI STAR IMPLANT SYSTEM2Cleared 510(K)
- K123861AIDI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K121873AVINENT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K132242INNO SLA SUBMERGED IMPLANT SYSTEM2Cleared 510(K)
- K131682UD IMPLANT SYSTEM2Cleared 510(K)
- K132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM2Cleared 510(K)
- K131165ANKER DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K123155LUNA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K130999OSSEOSPEED PROFILE EV2Cleared 510(K)
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- K130462PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT2Cleared 510(K)
- K131451PALTOP DENTAL IMPLANT - STERILE ACCESSORIES2Cleared 510(K)
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- K123988ANYONETM INTERNAL IMPLANT SYSTEM2Cleared 510(K)
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- K123471ETII SA FIXTURE SYSTEM2Cleared 510(K)
- K130787QUANTUM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K122519DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM2Cleared 510(K)
- K122804ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K113539REVOIS PRO IMPLANT STSYEM2Cleared 510(K)
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- K123386PERIOTYPE X-PERT2Cleared 510(K)
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- K1221986.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K121281SIMPLI SIMPLER IMPLANT SYSTEM2Cleared 510(K)
- K123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM2Cleared 510(K)
- K123870XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K130221HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED2Cleared 510(K)
- K120089BIOGENESIS IMPLANT SYSTEM2Cleared 510(K)
- K113042REVOIS IMPLANT SYSTEM2Cleared 510(K)
- K121406INCLUSIVE TAPERED IMPLANT SYSTEM2Cleared 510(K)
- K122300T3 DENTAL IMPLANT2Cleared 510(K)
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- K120793Z-LOOK3 EVO SLM2Cleared 510(K)
- K111189SYNTEC DENTAL IMPLANT2Cleared 510(K)
- K113779CONELOG IMPLANT SYSTEM2Cleared 510(K)
- K122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS2Cleared 510(K)
- K121995TS FIXTURE SYSTEM2Cleared 510(K)
- K122052MINIFIX BALL MINIFIX ONE2Cleared 510(K)
- K122171MS SA IMPLANT SYSTEM2Cleared 510(K)
- K113113ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K122231XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K121047HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K121707LEW MDI O-BALL COLLARED IMPLANT,2Cleared 510(K)
- K120875B&W DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K121787BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS2Cleared 510(K)
- K120792TIXOS IMPLANT SYSTEM2Cleared 510(K)
- K113376NEOSS PROACTIVE TAPERED IMPLANT2Cleared 510(K)
- K113753ZIMMER DENTAL TAPERED SCREW-VENT X2Cleared 510(K)
- K120847ET/SS IMPLANT SYSTEM2Cleared 510(K)
- K112162CONICAL CONNECTION IMPLANTS2Cleared 510(K)
- K112532ET II BIO-SA FIXTURE SYSTEM2Cleared 510(K)
- K120414OSSEOSPEED PLUS2Cleared 510(K)
- K110425HC-BIOS DENTAL IMPLANT2Cleared 510(K)
- K120530DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S2Cleared 510(K)
- K103577TRINON Q & Q3 IMPLANT SYSTEM2Cleared 510(K)
- K120503CMI IMPLANT IS II ACTIVE2Cleared 510(K)
- K121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM2Cleared 510(K)
- K120198LOCATOR OVERDENTURE IMPLANT SYSTEM2Cleared 510(K)
- K111798STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...2Cleared 510(K)
- K112585TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM2Cleared 510(K)
- K112279QUANTUM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K120043CSM INTERNAL-R IMPLANT SYSTEM2Cleared 510(K)
- K112795PALTOP DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K112440AB DENTAL DEVICES IMPLANTS AND ACCESSORIES2Cleared 510(K)
- K113554CMI IMPLANT IS SYSTEM2Cleared 510(K)
- K110337UNIVERSAL MAXILLARY MOLAR2Cleared 510(K)
- K112758KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X102Cleared 510(K)
- K112540S-MINI IMPLANT SYSTEM2Cleared 510(K)
- K111364HAPTITE COATING IMPLANT SYSTEM2Cleared 510(K)
- K112875BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS2Cleared 510(K)
- K111162SLIM ONEBODY SYSTEM2Cleared 510(K)
- K112160TAPERED SCREW-VENT X IMPLANT2Cleared 510(K)
- K111889ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT2Cleared 510(K)
- K110955ANYRIDGE INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K111216OSSEOTITE 2 DENTAL IMPLANTS2Cleared 510(K)
- K112746DIOSLIMON IMPLANT SYSTEM2Cleared 510(K)
- K111120CSM SUBMERGED-R IMPLANT SYSTEM2Cleared 510(K)
- K111357STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K111287ASTRA TECH IMPLANT SYSTEM2Cleared 510(K)
- K111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL2Cleared 510(K)
- K103089SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS2Cleared 510(K)
- K103810KJ SUBMERGED SYSTEM2Cleared 510(K)
- K103790ACE TRIMARK TRICAM DENTAL IMPLANT2Cleared 510(K)
- K110548OSI O-BALL ABUTMENT HEAD IMPLANTS2Cleared 510(K)
- K110577OSSEOFUSE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K103194INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM2Cleared 510(K)
- K102034BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K101201STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,2Cleared 510(K)
- K100724OSSEOTITE II MODEL XIFOSSXXX2Cleared 510(K)
- K102635APOLONIA LASER IMPLANT SYSTEM2Cleared 510(K)
- K101913ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM2Cleared 510(K)
- K103537ET III SA ULTRA WIDE SYSTEM2Cleared 510(K)
- K101732ASTRA TECH IMPLANT SYSTEM2Cleared 510(K)
- K101945NEODENT IMPLANT SYSTEM2Cleared 510(K)
- K101225PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-12Cleared 510(K)
- K102822IMPLANT-ONE SYSTEM2Cleared 510(K)
- K093595CERAROOT IMPLANT SYSTEM2Cleared 510(K)
- K100932INCLUSIVE MINI IMPLANT2Cleared 510(K)
- K102981ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K100850COWELL IMPLANT SYSTEM2Cleared 510(K)
- K102436NOBEL ACTIVE 3.02Cleared 510(K)
- K093749GC AADVA IMPLANT SYSTEM2Cleared 510(K)
- K102308SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS2Cleared 510(K)
- K101755AIDI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K100100DIO STEADY EXTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K101545GENESIS IMPLANT SYSTEM2Cleared 510(K)
- K093562ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K101096HT III SA FIXTURE SYSTEM2Cleared 510(K)
- K101880TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT2Cleared 510(K)
- K101849BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT2Cleared 510(K)
- K101977TAPERED SCREW-VENT T IMPLANT2Cleared 510(K)
- K082800STAR/VENT INTERNAL HEX SCREW IMPLANT2Cleared 510(K)
- K101207NEODENT IMPLANT SYSTEM2Cleared 510(K)
- K100411VARIOUS DENTAL IMPLANTS2Cleared 510(K)
- K092261DEFCON TSA/TSH DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K082573SARGON NON-EXPANDABLE DENTAL IMPLANT2Cleared 510(K)
- K100511COTEC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K100902AEDIS(TM)2Cleared 510(K)
- K093630BIODENTA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K092507ZIT-Z2Cleared 510(K)
- K092542M2Cleared 510(K)
- K093889MODIFICATION TO: HG III ULTRA WIDE SYSTEM2Cleared 510(K)
- K093321BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM2Cleared 510(K)
- K093615SPI DENTAL IMPLANT, ELEMENT2Cleared 510(K)
- K091208GS III SYSTEM2Cleared 510(K)
- K091678HG II SHORT FIXTURE SYSTEM2Cleared 510(K)
- K093027STRAUMANN RC TEMPORARY ABUTMENTS2Cleared 510(K)
- K091387BTI DENTAL IMPLANT 5.5-6.52Cleared 510(K)
- K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM2Cleared 510(K)
- K091182CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 60002Cleared 510(K)
- K092555UNO NARROW IMPLANT2Cleared 510(K)
- K092674SIMPLER TOADSTOOL MINI IMPLANT2Cleared 510(K)
- K0931643.25 SPLINE TWIST IMPLANT, HA COATED2Cleared 510(K)
- K091051BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM2Cleared 510(K)
- K093352HG III FIXTURE SYSTEM2Cleared 510(K)
- K092434STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K092035BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION2Cleared 510(K)
- K092112BTI DENTAL IMPLANT TINY 2.5-3.02Cleared 510(K)
- K091878OSSEOLINK DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K090716BEGO SEMADOS S-LINE2Cleared 510(K)
- K091239ASTRA TECH IMPLANT SYSTEM2Cleared 510(K)
- K092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX2Cleared 510(K)
- K090174TSI; ERI2Cleared 510(K)
- K090377SINUS QUICK EB SYSTEM2Cleared 510(K)
- K090054ATLAS IMPLANT SYSTEM - WIDE PLUS2Cleared 510(K)
- K090154SPI DENTAL IMPLANT INICELL2Cleared 510(K)
- K083670UNIVERSAL, AESTHETICA, NATEA, NATURA2Cleared 510(K)
- K090825SQ IS SYSTEM2Cleared 510(K)
- K090527SINUS QUICK IT SYSTEM2Cleared 510(K)
- K090709CORTEX DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K082843MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K083669OBI2Cleared 510(K)
- K090452NEOSS IMPLANT SYSTEM 03.252Cleared 510(K)
- K083805ANKYLOS C/X DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K090005BRANEMARK INTEGRATION BIOHELIX IMPLANTS2Cleared 510(K)
- K090234SPECTRA SYSTEM DENTAL IMPLANTS 20082Cleared 510(K)
- K083633HS II SHORT FIXTURE SYSTEM2Cleared 510(K)
- K083586I-FIX SYSTEM2Cleared 510(K)
- K090049ATLAS IMPLANT SYSTEM- MINI PLUS2Cleared 510(K)
- K090237HG II FIXTURE SYSTEM2Cleared 510(K)
- K083869BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI2Cleared 510(K)
- K081748ONEPLANT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K083886SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 50042Cleared 510(K)
- K083543DENOVISMED DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K090260MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS2Cleared 510(K)
- K083550STRAUMANN DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K081419STRAUMANN DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K083205NOBELACTIVE 8.5 MM & 18.0 MM2Cleared 510(K)
- K083561NEOSS PROACTIVE IMPLANT2Cleared 510(K)
- K083067MS SYSTEM2Cleared 510(K)
- K083496CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS2Cleared 510(K)
- K083297PITT-EASY DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K082651ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K082639ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS2Cleared 510(K)
- K081751ADIN DENTAL IMPLANTS SYSTEM2Cleared 510(K)
- K082749OMNI-TIGHT2Cleared 510(K)
- K082838ORLUS MINI SCREW2Cleared 510(K)
- K082200KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.52Cleared 510(K)
- K081818BIOLOK MICRO-LOK IMPLANT SYSTEM2Cleared 510(K)
- K081806IDI IMPLANT SYSTEM2Cleared 510(K)
- K081128MOLAR IMPLANT2Cleared 510(K)
- K081900TEMPORARY TOOTH REPLACEMENT2Cleared 510(K)
- K073645SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM2Cleared 510(K)
- K082213GS III FIXTURE SYSTEM2Cleared 510(K)
- K0733685.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT2Cleared 510(K)
- K080559DIO SM IMPLANT SYSTEM2Cleared 510(K)
- K081653MDI MII ONE-PIECE IMPLANT, 2.9MM2Cleared 510(K)
- K081579INVENTUS IMPLANT SYSTEM2Cleared 510(K)
- K080156OSSEOSPEED TM PROFILE SYSTEM2Cleared 510(K)
- K081226SIMPACT IMPLANT SYSTEM2Cleared 510(K)
- K071803ARDS DENTAL IMPLANTS2Cleared 510(K)
- K080594MS SYSTEM (NARROW RIDGE)2Cleared 510(K)
- K081302RESCUE EXTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K080744HG II FIXTURE SYSTEM2Cleared 510(K)
- K081078NT/IT SYSTEM2Cleared 510(K)
- K080633SCREWINDIRECT DENTAL IMPLANTS2Cleared 510(K)
- K080224KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK2Cleared 510(K)
- K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)2Cleared 510(K)
- K080115I-MINI DENTAL IMPLANT2Cleared 510(K)
- K080713REACTIVE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K073070DIO BIOTITE-H IMPLANT SYSTEM2Cleared 510(K)
- K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEM2Cleared 510(K)
- K073622EASY GRIP DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K072595OMNI-TIGHT2Cleared 510(K)
- K080396OSSEOSPEED NARROW2Cleared 510(K)
- K080162UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT2Cleared 510(K)
- K070570DIO IMPLANT SYSTEM2Cleared 510(K)
- K080126DIO PROTEM IMPLANT SYSTEM2Cleared 510(K)
- K073058RESCUE INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K073465US/GS ULTRA WIDE SYSTEM2Cleared 510(K)
- K073486DENTIS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K073458BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)2Cleared 510(K)
- K073075FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K073713BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K070184DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT2Cleared 510(K)
- K073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX2Cleared 510(K)
- K072425JNE IMPLANT SYSTEM2Cleared 510(K)
- K080387HU II / HS II FIXTURE SYSTEM2Cleared 510(K)
- K073247US/SS/GS SYSTEM2Cleared 510(K)
- K073161REPLUS DENTAL IMPLANTS (HA)2Cleared 510(K)
- K073116EBI INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K073282BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM2Cleared 510(K)
- K073067ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS2Cleared 510(K)
- K072447PENTABORN2Cleared 510(K)
- K080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX2Cleared 510(K)
- K073268BIOHORIZONS INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K071148ATLAS IMPLANT SYSTEM2Cleared 510(K)
- K072959MS SYSTEM (DENTURE)2Cleared 510(K)
- K072363NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX2Cleared 510(K)
- K071240IMPLASA-HOECHST GMBH IMPLANTS2Cleared 510(K)
- K072917JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM2Cleared 510(K)
- K073142NOBELREPLACE HEXAGONAL IMPLANT2Cleared 510(K)
- K072871MS SYSTEM (PROVISIONAL)2Cleared 510(K)
- K070857NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM2Cleared 510(K)
- K072980NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS2Cleared 510(K)
- K073049SCREWPLUS DENTAL IMPLANTS (HA)2Cleared 510(K)
- K072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 51142Cleared 510(K)
- K073033LEGACY DENTAL IMPLANTS2Cleared 510(K)
- K072649SPI SYSTEM DENTAL IMPLANTS2Cleared 510(K)
- K062931IMPLUS IMPLANT SYSTEM2Cleared 510(K)
- K071161ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K072933SPI CONTACT PLATFORM O 4.0 MM2Cleared 510(K)
- K070935T.B.R. ZIRCONNECT2Cleared 510(K)
- K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K072896GS FIXTURE SYSTEM2Cleared 510(K)
- K062542Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX2Cleared 510(K)
- K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS2Cleared 510(K)
- K071070OLYMPUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K071851HDC STERILE SPIDER SCREW2Cleared 510(K)
- K070601MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K063861GS SYSTEM2Cleared 510(K)
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- K071370NOBELACTIVE INTERNAL CONNECTION IMPLANT2Cleared 510(K)
- K070841ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS2Cleared 510(K)
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- K070568DIO PROTEM IMPLANT SYSTEM2Cleared 510(K)
- K070905ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K0633413I OSSEOTITE CERTAIN DENTAL IMPLANTS2Cleared 510(K)
- K063779OSSEOSPEED 4.0S-6MM, MODEL 246192Cleared 510(K)
- K063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE2Cleared 510(K)
- K070022MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF92Cleared 510(K)
- K070483LEONE MONOIMPLANT FOR O-RING OVERDENTURE2Cleared 510(K)
- K070182ZYGOMA IMPLANT (IMMEDIATE FUNCTION)2Cleared 510(K)
- K063216RESCUE INTERNAL IMPLANT SYSTEM2Cleared 510(K)
- K063874DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K063364ALPHA BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K061971ZIRCONIA IMPLANT2Cleared 510(K)
- K061629CERTAIN PREVAIL DENTAL IMPLANT2Cleared 510(K)
- K062432NANOTITE DENTAL IMPLANTS2Cleared 510(K)
- K063523ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP42Cleared 510(K)
- K070007SPI ELEMENT PLATFORM O 4.0 MM2Cleared 510(K)
- K063718SFB AND CFB IMPLANTS - 5.0 PLATFORM2Cleared 510(K)
- K062936NOBELPERFECT CONICAL CONNECTION2Cleared 510(K)
- K062367MINISCREWS ANCHORING SYSTEM, M.A.S.2Cleared 510(K)
- K062566NOBELREPLACE TAPERED CONICAL CONNECTION2Cleared 510(K)
- K062044THE 5.0 X 6.0MM DENTAL IMPLANT2Cleared 510(K)
- K062030US SYSTEM2Cleared 510(K)
- K062051SS SYSTEM2Cleared 510(K)
- K062156SUPER ORTHODONTIC SCREW2Cleared 510(K)
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- K061319SPECTRA SYSTEM2Cleared 510(K)
- K061717ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED2Cleared 510(K)
- K061410SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT2Cleared 510(K)
- K052968MODIFICATION TO: ORLUS MINI SCREW2Cleared 510(K)
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- K061797SM IMPLANT SYSTEMS2Cleared 510(K)
- K060958STRAUMANN NARROW NECK IMPLANTS2Cleared 510(K)
- K061176STRAUMANN DENTAL IMPLANTS2Cleared 510(K)
- K061335ENHANCE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K061500SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS2Cleared 510(K)
- K061003SFB & CFB IMPLANTS2Cleared 510(K)
- K061169ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K060501IMPLANTIUM II2Cleared 510(K)
- K060500SPEEDY ORTHODONTIC SCREW2Cleared 510(K)
- K052254MYTIS ARROW XXXX2Cleared 510(K)
- K053629ANCHOR PLUS/NEO ANCHOR PLUS2Cleared 510(K)
- K060126ABSOANCHOR MICROIMPLANT2Cleared 510(K)
- K060957MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K060376SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-242Cleared 510(K)
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- K053354INTERMEZZO PLUS FIXTURE2Cleared 510(K)
- K051798OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM2Cleared 510(K)
- K053478ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K053384FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM2Cleared 510(K)
- K051719A.B. DENTAL DEVICES2Cleared 510(K)
- K053355BTI INTERNA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K053088SLACTIVE IMPLANTS2Cleared 510(K)
- K050586LEONE IMPLANT SYSTEM2Cleared 510(K)
- K050956TBR IDEA CONIC/CONIC2Cleared 510(K)
- K052654KLOCKNER DENTAL IMPLANT, MODEL S3M2Cleared 510(K)
- K052951ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K052997ZIMMER DENTAL ONE-PIECE IMPLANT2Cleared 510(K)
- K052369EXFEEL IMPLANT SYSTEM2Cleared 510(K)
- K053242PITT-EASY DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K052471HDC SPIDER SCREW2Cleared 510(K)
- K052733ALMITECH INC. DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K052490ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K053152BIOHORIZONS SINGLE-STAGE IMPLANT2Cleared 510(K)
- K052061MODUS IMF SCREWS 2.02Cleared 510(K)
- K050970MILO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K051859SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K052419MAXIMUS 3.0 AND OS IMPLANTS2Cleared 510(K)
- K051552O.A.S.I. SYSTEM2Cleared 510(K)
- K0514613I OSSEOTITE DENTAL IMPLANTS2Cleared 510(K)
- K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS2Cleared 510(K)
- K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K051018INTERMEZZO IMPLANT SYSTEMS2Cleared 510(K)
- K051576AVANA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K050635ALLFIM IMPLANT SYSTEMS2Cleared 510(K)
- K051502SPI DENTAL IMPLANT2Cleared 510(K)
- K050478MEDICON IMF-ORION SCREWS2Cleared 510(K)
- K051189PREVAIL DENTAL IMPLANTS2Cleared 510(K)
- K050406NOBELSPEEDY IMPLANTS2Cleared 510(K)
- K050568ORLUS MINI SCREW2Cleared 510(K)
- K050705TIUNITE IMPLANTS2Cleared 510(K)
- K050393THE GUIDED SURGERY CONCEPT2Cleared 510(K)
- K0507124.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT2Cleared 510(K)
- K050258GROOVY IMPLANTS2Cleared 510(K)
- K050506PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS2Cleared 510(K)
- K040757SIC PRO2Cleared 510(K)
- K050408BICON ORTHODONTIC IMPLANT SYSTEM2Cleared 510(K)
- K043195NEO IMPLANT SYSTEM2Cleared 510(K)
- K050257LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)2Cleared 510(K)
- K042971TITAN DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 43202Cleared 510(K)
- K042345LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)2Cleared 510(K)
- K031568BICONITE SURFACE TREATMENT2Cleared 510(K)
- K042637THE 5.0 X 6.0MM DENTAL IMPLANT2Cleared 510(K)
- K042339NEOPLANT IMPLANT SYSTEM2Cleared 510(K)
- K041271STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K040170FRIADENT PLUS DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K041136MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS2Cleared 510(K)
- K041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM2Cleared 510(K)
- K042462AMERICAN DENTAL IMPLANT2Cleared 510(K)
- K042354MODIFICATION TO: CRESCO TI IMPLANT CONCEPT2Cleared 510(K)
- K042429THE PRODIGY SYSTEM DENTAL IMPLANTS2Cleared 510(K)
- K042289MDI ORTHO2Cleared 510(K)
- K040143MONORAIL2Cleared 510(K)
- K041655BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)2Cleared 510(K)
- K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTS2Cleared 510(K)
- K041509ANKYLOS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K041876NOBELDIRECT OD IMPLANT2Cleared 510(K)
- K041527AARHUS ANCHORAGE SYSTEM2Cleared 510(K)
- K041492ASTRA TECH IMPLANTS - DENTAL SYSTEM2Cleared 510(K)
- K041368DENTIUM CO., LTD. IMPLANTIUM2Cleared 510(K)
- K041938MAXIMUS OS (OVERDENTURE SYSTEM)2Cleared 510(K)
- K041759ACE CONNECT INTERNAL CONNECTION2Cleared 510(K)
- K040946ANKYLOS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K033984STRAUMANN DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K041402MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS2Cleared 510(K)
- K040807MIS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K040891KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)2Cleared 510(K)
- K040983LORENZ SELF-DRILLING IMF SCREW2Cleared 510(K)
- K033171NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING2Cleared 510(K)
- K033699LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 085862Cleared 510(K)
- K033630MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK2Cleared 510(K)
- K040714HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K040643BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES2Cleared 510(K)
- K034067ZTI IMPLANTS SYSTEM, DRM IMPLANTS2Cleared 510(K)
- K034014SPI CONTACT DENTAL IMPLANT2Cleared 510(K)
- K032454SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)2Cleared 510(K)
- K033767DUAL TOP ANCHOR SYSTEM SCREWS2Cleared 510(K)
- K030685TEETH IN AN HOUR - ARK IMPLANT CONCEPT2Cleared 510(K)
- K034022UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES2Cleared 510(K)
- K0322633I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR2Cleared 510(K)
- K033483KLS-MARTIN ORTHO ANCHORAGE SYSTEM2Cleared 510(K)
- K033922MODIFICATION TO ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K031936OSTEOMED ORTHODONTIC SCREW SYSTEM2Cleared 510(K)
- K031322INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS2Cleared 510(K)
- K033392IMMEDIATE STABILIZING IMPLANT (ISI)2Cleared 510(K)
- K032774RENOVA INTERNAL HEX IMPLANT SYSTEM2Cleared 510(K)
- K0334303I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG56152Cleared 510(K)
- K032351THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT2Cleared 510(K)
- K032750MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE2Cleared 510(K)
- K032302XIVE TG ABUTMENTS2Cleared 510(K)
- K0321405.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K032495THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM2Cleared 510(K)
- K031632OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS2Cleared 510(K)
- K0306143I DENTAL IMPLANTS2Cleared 510(K)
- K022258B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K012681ANKYLOS2Cleared 510(K)
- K032284XIVE TG DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K032158XIVE DENTAL IMPLANT SYSTEM MULTIPLE2Cleared 510(K)
- K031674MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K031106IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX2Cleared 510(K)
- K030639XIVE 3.0 DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K031475OSSEOTITE NT CERTAIN IMPLANTS2Cleared 510(K)
- K031345NOBEL DIRECT, MODELS 30937, 309382Cleared 510(K)
- K031055ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K024111ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED2Cleared 510(K)
- K030243ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,43142Cleared 510(K)
- K030007ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K030689SPI ELEMENT DENTAL IMPLANT O 3.5 MM2Cleared 510(K)
- K024004XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K030463MODIFICATION TO THE MAESTRO SYSTEM2Cleared 510(K)
- K024044SABER TECH IMPLANTS SYSTEM2Cleared 510(K)
- K030257NOBEL PERFECT IMPLANT SYSTEM2Cleared 510(K)
- K023705BICON TRANSITIONAL IMPLANT (BTI) SYSTEM2Cleared 510(K)
- K023580STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K023952REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE2Cleared 510(K)
- K0220093I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS2Cleared 510(K)
- K0101856.0 X 5.7MM DENTAL IMPLANT2Cleared 510(K)
- K021915TRANSITIONAL IMPLANTS2Cleared 510(K)
- K023067IMTEC SENDAX MDI ORTHO6 AND ORTHO82Cleared 510(K)
- K014050HEX-LOCK TEMPORARY ABUTMENT2Cleared 510(K)
- K022562VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION2Cleared 510(K)
- K023336OCO DENTAL IMPLANT (5.0MM DIAMETER)2Cleared 510(K)
- K022424REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 601622Cleared 510(K)
- K023113REPLACE TIUNITE ENDOSSEOUS IMPLANT2Cleared 510(K)
- K022912POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K022859ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K0221133I DENTAL IMPLANT ACCESSORIES2Cleared 510(K)
- K012473VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT2Cleared 510(K)
- K021355ENDOSSEOUS IMPLANT2Cleared 510(K)
- K0118793A DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K022425SCREWLINE2Cleared 510(K)
- K021322ENDOSSOUS IMPLANTS2Cleared 510(K)
- K022038SPI ONETIME DENTAL IMPLANT2Cleared 510(K)
- K021318XIVE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K021045ERA IMPLANT2Cleared 510(K)
- K021833MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K021584REPLACE SCALLOPED MARGIN IMPLANT SYSTEM2Cleared 510(K)
- K010132KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S42Cleared 510(K)
- K020646REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 601622Cleared 510(K)
- K014235OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES2Cleared 510(K)
- K020617NSI HEXED AND NON-HEXED IMPLANT SYSTEM2Cleared 510(K)
- K021244ACE HA SCREW DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K011524IMMEDIATE STABILIZING DEVICE (ISD)2Cleared 510(K)
- K013067FRIALOC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K014214SULZER DENTAL CERAMIC SYSTEM-SPLINE2Cleared 510(K)
- K020645MODIFICATION TO THE MAESTRO SYSTEM2Cleared 510(K)
- K013867XIVE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K020391STERN MICRO ERA ATTACHMENT SYSTEM2Cleared 510(K)
- K001638O-RING PROSTHETIC ATTACHMENT2Cleared 510(K)
- K020096ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K013891SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT2Cleared 510(K)
- K020133MODIFICATION TO THE MAESTRO SYSTEM2Cleared 510(K)
- K0134943.75MM AND 5.0MM SPLINE TWIST IMPLANT2Cleared 510(K)
- K013383BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K013438FRIALIT-2 ESTHETICBASE ABUTMENT2Cleared 510(K)
- K013798PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K981052CRESCO TI IMPLANT CONCEPT2Cleared 510(K)
- K013570OSSEOTITE DENTAL IMPLANTS2Cleared 510(K)
- K013682MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT2Cleared 510(K)
- K011502CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM2Cleared 510(K)
- P800035PERI-OSS2PMA Approval
- K0129113I LOCATER ABUTMENT SYSTEM2Cleared 510(K)
- K011574UNIPLANT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K010882BLUE SKY BIO DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K010619UCLA AND UNIVERSAL ABUTMENTS2Cleared 510(K)
- K010467UNIVERSAL DENTAL COPING (UDC)2Cleared 510(K)
- K003191MIS IMPLANT SYSTEM DECIVE2Cleared 510(K)
- K000035OMNICARE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K011223QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K002241QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K991250QUANTUM VERSATILITY IMPLANT SYSTEM2Cleared 510(K)
- K003620NSI HEXED AND NON-HEXED IMPLANT SYSTEM2Cleared 510(K)
- K0120553.25MM SPLINE TWIST IMPLANT2Cleared 510(K)
- K012757ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K003552ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K991822ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH2Cleared 510(K)
- K012299MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K003045HA-TI (HAND TITANIUM SCREW) IMPLANT2Cleared 510(K)
- K003818TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS2Cleared 510(K)
- K011245ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM2Cleared 510(K)
- K011028SCREW-VENT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K002037LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K011038TAPER-LOCK DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K010458THE MAESTRO SYSTEM2Cleared 510(K)
- K010291ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K000889SENOJ IMPLANT SYSTEM2Cleared 510(K)
- K003271MODIFICATION TO ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K010386DUO-DENT DENTAL IMPLANT2Cleared 510(K)
- K010343BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.3162Cleared 510(K)
- K002075ACE SDS 3.75MM SCREW DENTAL IMPLANT2Cleared 510(K)
- K010142OCO DENTAL IMPLANT2Cleared 510(K)
- K010073SPLINE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K003226THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K0012592-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K002513ASTRA TECH IMPLANTS - DENTAL SYSTEM2Cleared 510(K)
- K002614ADVENT IMPLANT SYSTEM2Cleared 510(K)
- K002475REPLACE TPS COATED IMPLANTS2Cleared 510(K)
- K002374ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT2Cleared 510(K)
- K002188SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,2Cleared 510(K)
- K000643INPLANT ORTHODONTIC ANCHOR SYSTEM2Cleared 510(K)
- K001786TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG2Cleared 510(K)
- K994174FRIALIT-2 MH-2 ABUTMENT2Cleared 510(K)
- K000018BRANEMARK NOVUM2Cleared 510(K)
- K993129UCLA/UNIVERSAL ABUTMENT2Cleared 510(K)
- K994376FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA2Cleared 510(K)
- K994257LOCATOR IMPLANT ANCHOR2Cleared 510(K)
- K994119SYNOCTA ANGLED ABUTMENTS2Cleared 510(K)
- K993894LIFECORE SINGLE TOOTH ABUTMENT SYSTEM2Cleared 510(K)
- K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K992937DENTAL IMPLANT2Cleared 510(K)
- K000099CAMLOG SCREW IMPLANT SYSTEM2Cleared 510(K)
- K000100CAMLOG ROOTFORM IMPLANT SYSTEM2Cleared 510(K)
- K000065CAMLOG CYLINDER IMPLANT SYSTEM2Cleared 510(K)
- K993595NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)2Cleared 510(K)
- K984297MAGNA ABUTMENT2Cleared 510(K)
- K994037THE 4.5MM DIAMETER BICON DENTAL IMPLANT2Cleared 510(K)
- K993560FRIALIT-2 BONE PROFILER2Cleared 510(K)
- K993095FRIALIT-2 SELECT COMPONENTS2Cleared 510(K)
- K992538AMORPHOUS DIAMOND COATED SCREW2Cleared 510(K)
- K992512ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA2Cleared 510(K)
- K992334ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING2Cleared 510(K)
- K9919473I CERAMIC ABUTMENT SYSTEM2Cleared 510(K)
- K991283DYNA TORQ TORQUE WRENCH, TORQUE WRENCH2Cleared 510(K)
- K983120BICORTICAL SCREW2Cleared 510(K)
- K990342SYNOCTA PROSTHETICS2Cleared 510(K)
- K990304MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM2Cleared 510(K)
- K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K991053ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)2Cleared 510(K)
- K981141SARGON IMMEDIATE LOAD IMPLANT, MODEL D2Cleared 510(K)
- K984536REMOVABLE CUFF ABUTMENT2Cleared 510(K)
- K982925LAMINOSS DENTAL IMPLANT2Cleared 510(K)
- K984104ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K991436STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION2Cleared 510(K)
- K990367PDQ AND PDQ-TI ABUTMENT2Cleared 510(K)
- K990983MODIFICATION TO IMTEC SENDAX MDI2Cleared 510(K)
- K990277O-RING ABUTMENT2Cleared 510(K)
- K981858ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW2Cleared 510(K)
- K983742ITI DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K984287PROVISIONAL DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K984198WIDE BODY ABUTMENTS2Cleared 510(K)
- K982488BICON BONE SCREW SYSTEM2Cleared 510(K)
- K981997POSI-STOP/POSI-TRAC SYSTEM2Cleared 510(K)
- K983563IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I2Cleared 510(K)
- K983347OSSEOTITE DENTAL IMPLANTS2Cleared 510(K)
- K974738ASTRA TECH IMPLANT DENTAL SYSTEM2Cleared 510(K)
- K983786STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION2Cleared 510(K)
- K982576FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-24762Cleared 510(K)
- K982492IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES2Cleared 510(K)
- K982305SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT2Cleared 510(K)
- K982111VARIOUS DENTAL IMPLANTS2Cleared 510(K)
- K980630FRIALIT-2 CORABASE2Cleared 510(K)
- K9800833I ORTHODONTIC ABUTMENT, ORTHOBUTMENT2Cleared 510(K)
- K974106ICON IMPLANT SYSTEM2Cleared 510(K)
- K974123BRANEMARK SYSTEM DEC 600 DRILLING UNIT2Cleared 510(K)
- K980620DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM2Cleared 510(K)
- K981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB2Cleared 510(K)
- K980460ONPLANT ORTHODONTIC SYSTEM2Cleared 510(K)
- K980549OSSEOTITE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K974828BRANEMARK SYSTEM(R) EBON(TM) FIXTURE2Cleared 510(K)
- K974737ASTRA TECH IMPLANT DENTAL SYSTEM2Cleared 510(K)
- K980698ASTRA TECH IMPLANTS - DENTAL SYSTEM2Cleared 510(K)
- K980442CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM2Cleared 510(K)
- K980439REPLACE CYLINDRICAL IMPLANTS2Cleared 510(K)
- K974628FRIALIT-2 PROTECT ABUTMENT2Cleared 510(K)
- K980374IMPLANT SITE DILATORS2Cleared 510(K)
- K9748563.25MM SIMPLER THREADED DENTAL IMPLANT2Cleared 510(K)
- K9748574.0MM SIMPLER THREADED DENTAL IMPLANT2Cleared 510(K)
- K9744014.0MM SIMPLER ONE THREADED DENTAL IMPLANT2Cleared 510(K)
- K974280ABUTMENT - COMPLETE2Cleared 510(K)
- K9744033.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT2Cleared 510(K)
- K9744023.25 MM SIMPLER ONE THREADED DENTAL IMPLANT2Cleared 510(K)
- K9744044.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT2Cleared 510(K)
- K974359FRIALIT-2 CYLINDER2Cleared 510(K)
- K974358FRIALIT -2 SCREW2Cleared 510(K)
- K974126IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW2Cleared 510(K)
- K970572DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET2Cleared 510(K)
- K973926O BUTMENT HS IMPLANT2Cleared 510(K)
- K973423STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT2Cleared 510(K)
- K973433STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT2Cleared 510(K)
- K973771DENTAL/SURGICAL DRILLS, BURS, TAPS2Cleared 510(K)
- K973353BONDING BASE2Cleared 510(K)
- K973402STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K972351SENDAX MDI (MINI DENTAL IMPLANT)2Cleared 510(K)
- K973521VARIABLE PARALLEL PIN2Cleared 510(K)
- K954030BONE-LOCK2Cleared 510(K)
- K973049IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM2Cleared 510(K)
- K972769OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 42Cleared 510(K)
- K970499BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM2Cleared 510(K)
- K972417THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K972313THE MAESTRO SYSTEM2Cleared 510(K)
- K961381KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS2Cleared 510(K)
- K950261DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES2Cleared 510(K)
- K950260QUICK COUPLING DEVICE FOR DENTAL PROSTHESES2Cleared 510(K)
- K9724443I INNOVATIVE IMPLANTS AND COVER SCREWS2Cleared 510(K)
- K965032THE PERIOSEAL DENTAL IMPLANT2Cleared 510(K)
- K972029BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM2Cleared 510(K)
- K954758ROOTFORM DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K963520IMZ TWIN PLUS SCREW2Cleared 510(K)
- K963521IMZ TWIN PLUS - CYLINDER2Cleared 510(K)
- K971578ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K970752SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM2Cleared 510(K)
- K970127EDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
- K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT2Cleared 510(K)
- K962753KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)2Cleared 510(K)
- K961631ODONT HEX SYSTEM2Cleared 510(K)
- K971196ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K952905MINIMATIC VARIOUS IMPLANT SYSTEMS2Cleared 510(K)
- K963030LEIBINGER IMF SCREW2Cleared 510(K)
- K964739STERI-OSS TIODIZED SCREW2Cleared 510(K)
- K965077SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS2Cleared 510(K)
- K964220REPLACE TITANIUM IMPLANT SYSTEM2Cleared 510(K)
- K964046DENTSPLY PRECISION TORQUE SYSTEM2Cleared 510(K)
- K963495IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K963522IMZ 2000 INTERLOCK 12/3 - SCREW2Cleared 510(K)
- K965135LIFECORE CONICAL ABUTMENT2Cleared 510(K)
- K964768THREADLOC DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K963945STERI-OSS GOLD ATTACHMENT SYSTEM2Cleared 510(K)
- K964944ROUND DENTAL BUR2Cleared 510(K)
- K962576SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K964330BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)2Cleared 510(K)
- K963951AS 123 PROSTHETIC INSTRUMENTATION SYSTEM2Cleared 510(K)
- K961665O BUTMENT ET IMPLANT2Cleared 510(K)
- K963224STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT2Cleared 510(K)
- K960868B.A.S.I.C. DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K963401TPS APICAL IMPLANT2Cleared 510(K)
- K963121FIXTURE MOUNT KIT2Cleared 510(K)
- K962844REPLACE TPS COATED IMPLANTS2Cleared 510(K)
- K962845REPLACE HA COATED IMPLANTS2Cleared 510(K)
- K962610DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES2Cleared 510(K)
- K9620143I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.2Cleared 510(K)
- K962394IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS2Cleared 510(K)
- K962647ANGLED ABUTMENT2Cleared 510(K)
- K961387MT-X2Cleared 510(K)
- K961386MT-2A2Cleared 510(K)
- K961385MT-3A2Cleared 510(K)
- K961384MT-22Cleared 510(K)
- K961383MT12Cleared 510(K)
- K961382MT1A2Cleared 510(K)
- K962465TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS2Cleared 510(K)
- K962449OSTEO COMPACTION KIT2Cleared 510(K)
- K962403NOBLEPHARMA WIDE ACCESSORIES2Cleared 510(K)
- K962106SPLINE DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K961861VARIOUS DENTAL IMPLANTS WITH COVER SCREWS2Cleared 510(K)
- K962023PLASTIC PROTECTION HEALING CAPS2Cleared 510(K)
- K960886STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS2Cleared 510(K)
- K9604173I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS2Cleared 510(K)
- K960398STERI-OSS APICAL IMPLANT2Cleared 510(K)
- K954432CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM2Cleared 510(K)
- K962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE2Cleared 510(K)
- K961737CERA ONE ABUTMENT SYSTEM2Cleared 510(K)
- K933705LAMINOSS DENTAL IMPLANT2Cleared 510(K)
- K960634TITANIUM HEALING CAPS2Cleared 510(K)
- K960899IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW2Cleared 510(K)
- K961020STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS2Cleared 510(K)
- K960900IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW2Cleared 510(K)
- K954605ACE CYLINDER DENTAL IMPLANT2Cleared 510(K)
- K954513ACE SREW DENTLA IMPLANT SYSTEM2Cleared 510(K)
- K960022OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS2Cleared 510(K)
- K960979SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP2Cleared 510(K)
- K960639ABUTMENT SELECTION KIT2Cleared 510(K)
- K961005SARGON IMMEDIATE LOAD IMPLANT2Cleared 510(K)
- K955332OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW2Cleared 510(K)
- K9543473I STANDARD THREADED IMPLANT2Cleared 510(K)
- K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K960026BIOHORIZONS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K960111KIS MT42Cleared 510(K)
- K960110KIS MT32Cleared 510(K)
- K960112KIS MT52Cleared 510(K)
- K955281ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES2Cleared 510(K)
- K945849FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING2Cleared 510(K)
- K945848FRIALIT(R)-2 DENTAL IMPLANT2Cleared 510(K)
- K945847FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE2Cleared 510(K)
- K960371INTERPORE THREADED IMPLANT2Cleared 510(K)
- K9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K931647PHOENIX 4.0 MM HA COATED DENTAL IMPLANT2Cleared 510(K)
- K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K9554273I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS2Cleared 510(K)
- K960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS2Cleared 510(K)
- K9554283I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS2Cleared 510(K)
- K943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K955697ABUTMENT RETRIEVAL KIT2Cleared 510(K)
- K955492INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT2Cleared 510(K)
- K955372BALL ATTACHMENT SYSTEM2Cleared 510(K)
- K955048KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM2Cleared 510(K)
- K954865RESTORE HA DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K933646CAL-FORM DENTAL IMPLANTS2Cleared 510(K)
- K953101PARAGON IMPLANT SYSTEM2Cleared 510(K)
- K953558KIS II LG HEX SCREW & CYLINDER IMPLANTS2Cleared 510(K)
- K946345INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K946319INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K953234SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B32Cleared 510(K)
- K952985WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS2Cleared 510(K)
- K952999UNCOATED SCREW IMPLANT 3.75, 4.0-B52Cleared 510(K)
- K952998TP SCREW IMPLANT 3.75, 4.0-B52Cleared 510(K)
- K952997PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED2Cleared 510(K)
- K953000WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM2Cleared 510(K)
- K953001TP-4K SCREW IMPLANT 3.3, 3.75, 4.02Cleared 510(K)
- K952996HA/TP COATED CYLINDER IMPLANT 3.3,4.02Cleared 510(K)
- K952994TP-4 WIDE CYLINDER IMPLANTS2Cleared 510(K)
- K952992PROSTHETICS 4MM2Cleared 510(K)
- K952991WIDE SCREW HA-5B, CYL-HA-52Cleared 510(K)
- K954539LG HEX PROSTHETICS2Cleared 510(K)
- K952917STERI-OSS IMMEDIATE PLACEMENT IMPLANT2Cleared 510(K)
- K953158HAWN UNIVERSAL2Cleared 510(K)
- K946311INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K953435BRANEMARK RADIOGRAPHIC DEPTH GUAGE2Cleared 510(K)
- K953774BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY2Cleared 510(K)
- K9502043I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)2Cleared 510(K)
- K944225DUAL INTEGRATOR DENTAL IMPLANT2Cleared 510(K)
- K926371ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS2Cleared 510(K)
- K953836ABUTMENT2Cleared 510(K)
- K953775BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)2Cleared 510(K)
- K952592OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS2Cleared 510(K)
- K943180INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K926370STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS2Cleared 510(K)
- K926367PHOENIX 3.25 MM HA COATED DENTAL IMPLANT2Cleared 510(K)
- K926366PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT2Cleared 510(K)
- K926309PHOENIX 4.0 MM DENTAL IMPLANT2Cleared 510(K)
- K926311PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS2Cleared 510(K)
- K952886BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM2Cleared 510(K)
- K952685BRANEMARK SYSTEM DRILLS AND COUNTERSINKS2Cleared 510(K)
- K952634OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW2Cleared 510(K)
- K953281HA, TP CYLINDER OVAL2Cleared 510(K)
- K953280HA, TP CYLINDER, UNIHOLE2Cleared 510(K)
- K953237PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'2Cleared 510(K)
- K950066DENTAL IMPLANT ENDOSSEOUS2Cleared 510(K)
- K953235SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K32Cleared 510(K)
- K953236CYLINDER IMPLANTS HA, TP, GRADE 32Cleared 510(K)
- K953139KIS-- FOUR HOLE CYLINDER2Cleared 510(K)
- K953331COMBINATION KIT2Cleared 510(K)
- K953380LABORATORY SUPPLIES2Cleared 510(K)
- K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K953103LAPPING TOOL KIT2Cleared 510(K)
- K952676BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM2Cleared 510(K)
- K951611IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT2Cleared 510(K)
- K951609IMZ - DENTAL IMPLANT SURGICAL TRAY2Cleared 510(K)
- K952989WIDE STR-TP-4K, PROS STR, CLY-STR-TP 42Cleared 510(K)
- K952988WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS2Cleared 510(K)
- K951615IMZ - DENTAL IMPLANT COMPONENTS2Cleared 510(K)
- K951610IMZ - DENTAL IMPLANT2Cleared 510(K)
- K951612IMZ - DENTAL IMPLANT COMPONENTS2Cleared 510(K)
- K951614IMZ - DENTAL IMPLANT2Cleared 510(K)
- K951617IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT2Cleared 510(K)
- K951618IMZ - DENTAL IMPLANT O-RING ATTACHMENT2Cleared 510(K)
- K952434ENDOPORE DENTAL IMPLANT ABUTMENTS2Cleared 510(K)
- K951606KIS-II IMPLANT FIXTURES2Cleared 510(K)
- K945706BONE DRILL2Cleared 510(K)
- K950575BIO-VENT IMPLANT2Cleared 510(K)
- K950579MICRO-VENT IMPLANT2Cleared 510(K)
- K950576BIO-VENT X IMPLANT2Cleared 510(K)
- K950578SCREW-VENT IMPLANT2Cleared 510(K)
- K950577SWEDE-VENT IMPLANT2Cleared 510(K)
- K9515533I ASYST ABUTMENT PACKAGE SYSTEM2Cleared 510(K)
- K952644STERI-OSS SELF TAPING IMPLANT2Cleared 510(K)
- K952120TORQUE LIMITER2Cleared 510(K)
- K9524483.3MM ACCESSORIES2Cleared 510(K)
- K946198IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR2Cleared 510(K)
- K941393ITI ANGLED ABUTMENT2Cleared 510(K)
- K951065SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS2Cleared 510(K)
- K951937BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)2Cleared 510(K)
- K952193OSTEOTOMES2Cleared 510(K)
- K944327INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K950893KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS2Cleared 510(K)
- K941608INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING2Cleared 510(K)
- K950446BONE CUTTING INSTRUMENT AND ACCESSORIES2Cleared 510(K)
- K912521DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH2Cleared 510(K)
- K930868DYNA IMPLANT DESIGN2Cleared 510(K)
- K944725KIS-II STR FIXTURES2Cleared 510(K)
- K950936BONE CUTTING INSTRUMENT AND ACCESSORIES2Cleared 510(K)
- K943681STERI-OSS SCALER FOR DENTAL IMPLANTS2Cleared 510(K)
- K945398BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE2Cleared 510(K)
- K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)2Cleared 510(K)
- K944158STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT2Cleared 510(K)
- K943720ITI TRANSVERSAL SCREWING SYSTEM2Cleared 510(K)
- K944943OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL2Cleared 510(K)
- K9355443I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION2Cleared 510(K)
- K944683BRANEMARK SYSTEM 3.3MM FIXTURE2Cleared 510(K)
- K946129IMPLANT BODY DEPTH GAUGE/TRYIN2Cleared 510(K)
- K946113IMPLANT BODY RETRIEVER/REMOVER2Cleared 510(K)
- K943984KIS-II NON-ANGULATED ABUTMENTS2Cleared 510(K)
- K943971KIS-II IMPLANT FIXTURES2Cleared 510(K)
- K944964BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM2Cleared 510(K)
- K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM2Cleared 510(K)
- K944962BRANEMARK SYSTEM 17 ANGULATED ABUTMENT2Cleared 510(K)
- K944963BRANEMARK SYSTEM SMILINE II2Cleared 510(K)
- K945300ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT2Cleared 510(K)
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- K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)2Cleared 510(K)
- K944356KIS-II IMPLANT SYSTEM/DRILLS2Cleared 510(K)
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- K941247VIDENT IMPAC INFINITE POSITION ABUTMENT2Cleared 510(K)
- K940998IMPAC TORQUE WRENCH2Cleared 510(K)
- K925849ZEST IMPLANT ANCHOR2Cleared 510(K)
- K941575SMOOTH FIT2Cleared 510(K)
- K941620LORENZ SURGICAL CYLINDER DENTAL IMPLANT2Cleared 510(K)
- K941619LORENZ SURGICAL THREADED DENTAL IMPLANT2Cleared 510(K)
- K941621LORENZ SURGICAL FINNED DENTAL IMPLANT2Cleared 510(K)
- K933532SELF TAPPING DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K925555STERI-OSS THREADED TPS HEX SERIES IMPLANT2Cleared 510(K)
- K925481STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT2Cleared 510(K)
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- K932168HEXLOCK/HEXLOCK SCREW2Cleared 510(K)
- K931785BRANEMARK SYSTEM DRILL CONTROLLER2Cleared 510(K)
- K934825BRANEMARK SYSTEM2Cleared 510(K)
- K934826BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC1042Cleared 510(K)
- K934827BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM2Cleared 510(K)
- K934495BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETE2Cleared 510(K)
- K913255CERAMIC(TM) ABUTMENT2Cleared 510(K)
- K925766BRANEMARK SYSTEM TEMPORARY SOLUTIONS2Cleared 510(K)
- K925490INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K922872INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.2Cleared 510(K)
- K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM2Cleared 510(K)
- K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM2Cleared 510(K)
- K924112HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II2Cleared 510(K)
- K930071SARGON CYLINDRO-BLADE IMPLANT2Cleared 510(K)
- K926101PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO2Cleared 510(K)
- K934668ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)2Cleared 510(K)
- K926102PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN2Cleared 510(K)
- K924589RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K925312HAND INSTRUMENT CALCULUS REMOVAL2Cleared 510(K)
- K923694DUO DENT2Cleared 510(K)
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- K933969TAPERED ABUTMENT AND RELATED COMPONENTS2Cleared 510(K)
- K931993ITI DISTANCE SYSTEM2Cleared 510(K)
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- K921805STRYKER PRECISION DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K933462CONICAL ABUTMENT2Cleared 510(K)
- K933193IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L2Cleared 510(K)
- K926305IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER2Cleared 510(K)
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- K922732INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER2Cleared 510(K)
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- K914041MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT2Cleared 510(K)
- K914043MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA2Cleared 510(K)
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- EBDCoating, Filling Material, Resin2Product Code
- EBECoating, Denture Hydrophilic, Resin2Product Code
- EBFMaterial, Tooth Shade, Resin2Product Code
- EBGCrown And Bridge, Temporary, Resin2Product Code
- EBHMaterial, Impression Tray, Resin1Product Code
- EBIResin, Denture, Relining, Repairing, Rebasing2Product Code
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- EHPClasp, Preformed1Product Code
- EHQCusp, Preformed1Product Code
- EHRPad, Denture, Over The Counter2Product Code
- EHSCushion, Denture, Over The Counter2Product Code
- EITApplicator, Rapid Wax, Dental2Product Code
- EJHAlloy, Metal, Base2Product Code
- EJJAlloy, Amalgam2Product Code
- EJKLiner, Cavity, Calcium Hydroxide2Product Code
- EJLBur, Dental1Product Code
- EJPArticulators1Product Code
- EJSAlloy, Other Noble Metal2Product Code
- EJTAlloy, Gold-Based Noble Metal2Product Code
- EJWClasp, Wire1Product Code
- EJXAnchor, Preformed1Product Code
- EKLPoint, Silver, Endodontic1Product Code
- EKMGutta-Percha1Product Code
- EKNPoint, Paper, Endodontic1Product Code
- EKODenture Preformed (Partially Prefabricated Denture)2Product Code
- ELEImplant, Subperiosteal2Product Code
- ELJTeeth, Artificial, Posterior With Metal Insert1Product Code
- ELKTeeth, Artificial, Backing And Facing1Product Code
- ELLTeeth, Porcelain2Product Code
- ELMDenture, Plastic, Teeth2Product Code
- ELNTeeth, Preformed Gold Denture1Product Code
- ELOCusp, Gold And Stainless Steel1Product Code
- ELRPost, Root Canal1Product Code
- ELSSplint, Endodontic Stabilizing2Product Code
- ELWMaterial, Impression2Product Code
- ELYMercury2Product Code
- ELZCrown, Preformed1Product Code
- EMACement, Dental2Product Code
- EMBZinc Oxide Eugenol1Product Code
- JERCleaner, Denture, Mechanical1Product Code
- KCRFacebow1Product Code
- KCSPantograph1Product Code
- KIFResin, Root Canal Filling2Product Code
- KLEAgent, Tooth Bonding, Resin2Product Code
- KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer1Product Code
- KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate1Product Code
- KONAdhesive, Denture, Polyacrylamide Polymer (Modified Cationic)3Product Code
- KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt1Product Code
- KOPAdhesive, Denture, Karaya1Product Code
- KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)1Product Code
- KORAdhesive, Denture, Karaya With Sodium Borate3Product Code
- KOSAdhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer3Product Code
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium1Product Code
- KXRApplicator, Resin1Product Code
- KXWAdhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer1Product Code
- KXXAdhesive, Denture, Karaya And Ethylene-Oxide Homopolymer1Product Code
- KXYPolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce3Product Code
- KZNScanner, Color2Product Code
- KZOInk, Arch Tracing1Product Code
- KZPSolution, Cement Dissolving2Product Code
- LBHVarnish, Cavity2Product Code
- LPKBone Grafting Material, For Dental Bone Repair2Product Code
- LYCBone Grafting Material, Synthetic2Product Code
- LZDJoint, Temporomandibular, Implant3Product Code
- MMTResin, Root Canal Filling Containing Chloroform3Product Code
- MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight3Product Code
- MPIGlenoid Fossa Prosthesis3Product Code
- MPJInterarticular Disc Prosthesis (Interpositional Implant)3Product Code
- MPLMandibular Condyle Prosthesis3Product Code
- MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief2Product Code
- NDPAccessories, Implant, Dental, Endosseous1Product Code
- NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation2Product Code
- NHAAbutment, Implant, Dental, Endosseous2Product Code
- NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter1Product Code
- NMEBur, Diamond Coated, Reprocessed1Product Code
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations2Product Code
- NPKBarrier, Synthetic, Intraoral2Product Code
- NPLBarrier, Animal Source, Intraoral2Product Code
- NPMBone Grafting Material, Animal Source2Product Code
- NPZBone Grafting Material, Dental, With Biologic Component3Product Code
- NQABiologic Material, Dental3Product Code
- NRQBlade-Form Endosseous Dental Implant2Product Code
- NUNBone Grafting Material, Human Source2Product Code
- NUXCleanser, Denture, Prescription1Product Code
- NYDEndodontic Kit2Product Code
- OATImplant, Endosseous, Orthodontic2Product Code
- NYEFixture Mount Kit1Product Code
- OFWRestorative Instrument And Component Tray2Product Code
- OFYDental Implant Surgical Tray1Product Code
- OIVDental Amalgam2Product Code
- PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish2Product Code
- PMEExternal Cleaning Solution2Product Code
- PNPDental Abutment Design Software For Dental Laboratory2Product Code
- POWCrown And Bridge, Long-Term Temporary, Resin2Product Code
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth2Product Code
- QJKIntraoral Camera2Product Code
- QRQNon-Irrigation Endosseous Dental Implant Drill Bits1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ASTRA TECH IMPLANTS - DENTAL SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
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