Anesthesiology
Review Panel
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- 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
- EBCSealant, Pit And Fissure, And Conditioner2Product Code
- 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
- EBLPin, Retentive And Splinting, And Accessory Instruments1Product Code
- EBODenture Repair Kit2Product Code
- EBPReliner, Denture, Over The Counter2Product Code
- EFDAmalgamator, Dental, Ac-Powered1Product Code
- EFTCleanser, Denture, Over The Counter1Product Code
- EGGAttachment, Precision, All1Product Code
- EHEDispenser, Mercury And/Or Alloy1Product Code
- EHOBar, Preformed1Product Code
- 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
- K252727Neodent InLab Validated Workflow2Cleared 510(K)
- K253341Custom Abutments AS2Cleared 510(K)
- K253312OrangeCAD Med Abutments2Cleared 510(K)
- K252320SIMDA Abutments2Cleared 510(K)
- K252343Atlantis® Abutments in Titanium2Cleared 510(K)
- K252248CEREC Tessera Abutment System2Cleared 510(K)
- K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants2Cleared 510(K)
- K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems2Cleared 510(K)
- K251547DESS Dental Smart Solutions2Cleared 510(K)
- K252384DESS® Dental Smart Solutions2Cleared 510(K)
- K252266S.I.N. Dental Implant System2Cleared 510(K)
- K250178Adin Customized Abutments2Cleared 510(K)
- K251497Elos Accurate Hybrid Base2Cleared 510(K)
- K252944LOCATOR® Angled Abutment2Cleared 510(K)
- K251294Bonafix Implant Abutments2Cleared 510(K)
- K242287SFIT Abutment2Cleared 510(K)
- K242768Customized Abutment and Screw2Cleared 510(K)
- K251471IPD Dental Implant Abutments2Cleared 510(K)
- K250721LOCATOR® Angled Abutment2Cleared 510(K)
- K251220NUVENTUS NV.C™ Prosthetic Components2Cleared 510(K)
- K241183ISO Abutment2Cleared 510(K)
- K250967Sherlock2Cleared 510(K)
- K243009MIST IC2Cleared 510(K)
- K242978Geo Abutment2Cleared 510(K)
- K243530Dynamic TiBase2Cleared 510(K)
- K250614Neodent Implant System - Custom Abutments2Cleared 510(K)
- K250639DESS Dental Smart Solutions2Cleared 510(K)
- K243824Preat Abutments2Cleared 510(K)
- K243521Conical Ti Base abutments2Cleared 510(K)
- K250295Dentsply Sirona Titanium Bases system2Cleared 510(K)
- K242542Medentika CAD/CAM Abutments2Cleared 510(K)
- K250081Atlantis® Abutments in Titanium2Cleared 510(K)
- K232383iPhysio® System2Cleared 510(K)
- K243278Custom Abutments2Cleared 510(K)
- K243478Straumann InLab Validated Workflow2Cleared 510(K)
- K243212DESS Dental Smart Solutions2Cleared 510(K)
- K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)2Cleared 510(K)
- K243272LOCATOR Angled Abutment2Cleared 510(K)
- K242030MegaGen Dental Implant Abutment2Cleared 510(K)
- K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)2Cleared 510(K)
- K240346NobelProcera Zirconia Implant Bridge2Cleared 510(K)
- K242819IPD Dental Implant Abutments2Cleared 510(K)
- K241616ALLONUS Tech Prosthetics2Cleared 510(K)
- K242025Elos Accurate® Hybrid Base™2Cleared 510(K)
- K242703LW Pre-milled Abutment2Cleared 510(K)
- K242686Neodent Implant System2Cleared 510(K)
- K242245Customized Abutment2Cleared 510(K)
- K241575Straumann® Anatomic Healing Abutments XC (AHA)2Cleared 510(K)
- K242340DESS Dental Smart Solutions2Cleared 510(K)
- K241170Dynamic TiBase; TRI Screws2Cleared 510(K)
- K240725PreXolid CAD/CAM abutments2Cleared 510(K)
- K241485TruAbutment DS; TruBase2Cleared 510(K)
- K234142TiGEN Abutment, PMMA Abutment and Scan Healing Abutment2Cleared 510(K)
- K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment2Cleared 510(K)
- K240982DESS Dental Smart Solutions2Cleared 510(K)
- K231932TDS (TECHWIN DENTAL SYSTEM)2Cleared 510(K)
- K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment2Cleared 510(K)
- K241063s-Clean ScanHealing Abutment2Cleared 510(K)
- K241032BellaTek Bars2Cleared 510(K)
- K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems2Cleared 510(K)
- K240570IPD Dental Implant Abutments2Cleared 510(K)
- K240603Ti-Base & Master Fix2Cleared 510(K)
- K233587LOCATOR Angled Abutment (Various)2Cleared 510(K)
- K233389EK Digital Abutments2Cleared 510(K)
- K233285KATANA Zirconia ONE For IMPLANT2Cleared 510(K)
- K231940BruxZir® NOW SRC2Cleared 510(K)
- K234112Customized Abutment2Cleared 510(K)
- K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System2Cleared 510(K)
- K233857Neodent Implant System – Custom Abutments2Cleared 510(K)
- K232528Protective Cap2Cleared 510(K)
- K240208DESS Dental Smart Solutions2Cleared 510(K)
- K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments2Cleared 510(K)
- K231132J & P Click Attachments2Cleared 510(K)
- K233167LW Implant System – Abutment2Cleared 510(K)
- K233083Osteon Precision Milled Suprastructure2Cleared 510(K)
- K231210DGA Abutment2Cleared 510(K)
- K231915Zfx Abutments2Cleared 510(K)
- K231753Oneday Implant Abutment2Cleared 510(K)
- K233194TS Abutment System2Cleared 510(K)
- K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium2Cleared 510(K)
- K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw2Cleared 510(K)
- K232170Ti Link Abutment2Cleared 510(K)
- K233316DESS Dental Smart Solutions2Cleared 510(K)
- K231072Anthogyr FlexiBase® titanium bases for Axiom® BL2Cleared 510(K)
- K231307Elos Accurate Customized Abutment2Cleared 510(K)
- K231411INNO SLA Submerged Hybrid Ti-Base System2Cleared 510(K)
- K232560Angled Abutment2Cleared 510(K)
- K231803Neodent Implant System - Zirconia Implant System2Cleared 510(K)
- K232750BTI Interna Prosthetic Components2Cleared 510(K)
- K232220SS Abutment System2Cleared 510(K)
- K232546Meta G UCLA Abutment2Cleared 510(K)
- K231559Multi-Unit DAS System2Cleared 510(K)
- K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems2Cleared 510(K)
- K231874AOT & T-L Abutment2Cleared 510(K)
- K232271SIMDA abutment2Cleared 510(K)
- K232151Dynamic TiBase2Cleared 510(K)
- K231413IPD Dental Implant Abutments2Cleared 510(K)
- K221972Warantec Custom Abutment2Cleared 510(K)
- K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems2Cleared 510(K)
- K231827BTI Dental Implant System UnicCa® – Aesthetic Post Abutments2Cleared 510(K)
- K231235LW UCLA Abutment2Cleared 510(K)
- K231079LW Retraction Cap2Cleared 510(K)
- K230317Elos Accurate Hybrid Base2Cleared 510(K)
- K231557ZENEX FreeMilling & CCM Cast Abutment2Cleared 510(K)
- K220253Eco Abutment, Multiunit Abutment2Cleared 510(K)
- K231455Implant-One System2Cleared 510(K)
- K231434DESS Dental Smart Solutions2Cleared 510(K)
- K230126Dentis s-Clean Regular Abutment2Cleared 510(K)
- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments2Cleared 510(K)
- K222026Neodent Implant System - Zirconia Implant System2Cleared 510(K)
- K221673Bonafix TiBase2Cleared 510(K)
- K230307Dentis i-Clean System2Cleared 510(K)
- K223535SMARTbase Abutment System2Cleared 510(K)
- K230246Dentis s-Clean SQ-SL Narrow Implant System2Cleared 510(K)
- K230523s-Clean Link Abutment Narrow2Cleared 510(K)
- K223663SIMDA Abutment2Cleared 510(K)
- K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs2Cleared 510(K)
- K221969IU Implant System Abutment2Cleared 510(K)
- K230203Dentis I-FIX Abutment2Cleared 510(K)
- K223677Titanium Abutment Blank Nobel Biocare N1 TCC2Cleared 510(K)
- K223634Customized Abutment2Cleared 510(K)
- K222636ET Abutment System2Cleared 510(K)
- K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)2Cleared 510(K)
- K230103Klockner Abutments2Cleared 510(K)
- K222469TIB Abutments2Cleared 510(K)
- K230143DESS Dental Smart Solutions2Cleared 510(K)
- K230069S.I.N. Dental Implant System2Cleared 510(K)
- K212394Implant-One Multi-Unit Abutment2Cleared 510(K)
- K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment System2Cleared 510(K)
- K221301DESS Dental Smart Solutions2Cleared 510(K)
- K222451SAVE GBR2Cleared 510(K)
- K223395Luna Dental Implant System2Cleared 510(K)
- K222913s-Clean Link Abutment2Cleared 510(K)
- K222976MU System2Cleared 510(K)
- K191111DD Solid Connect® CAD/CAM Abutments2Cleared 510(K)
- K222984BioClean Implant Restorative System2Cleared 510(K)
- K220390CreoDent Solidex Customized Abutment and Screw2Cleared 510(K)
- K222368MIST IC2Cleared 510(K)
- K222044Elos Accurate Customized Abutment2Cleared 510(K)
- K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment2Cleared 510(K)
- K222288DESS Dental Smart Solutions2Cleared 510(K)
- K222269DESS Dental Smart Solutions2Cleared 510(K)
- K220823Preat Abutments2Cleared 510(K)
- K222215IPD Dental Implant Abutments2Cleared 510(K)
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic Components2Cleared 510(K)
- K202144A.B. Dental Devices Dental Implants System2Cleared 510(K)
- K220339Esthetic Abutments Nobel Biocare N12Cleared 510(K)
- K221966Dynamic TiBase2Cleared 510(K)
- K221684Osstem Abutment System2Cleared 510(K)
- K221381KDG Abutments2Cleared 510(K)
- K220048NobelProcera Zirconia N1 Base2Cleared 510(K)
- K213961TruAbutment DS, TruBase2Cleared 510(K)
- K221019Osteon Precision Milled Suprastructure2Cleared 510(K)
- K220482Sherlock2Cleared 510(K)
- K220878Straumann TLX Variobase C2Cleared 510(K)
- K220440Dentis s-Clean Abutment Mini2Cleared 510(K)
- K220612PrimeLOC Attachment System2Cleared 510(K)
- K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA2Cleared 510(K)
- K211396Neoss Individual Prosthetics2Cleared 510(K)
- K220252High Retention Attachment System2Cleared 510(K)
- K213063TLX SRAs and TLX Gold Abutments2Cleared 510(K)
- K213432MIS Angulated multi-unit abutments2Cleared 510(K)
- K212628DESS Dental Smart Solutions2Cleared 510(K)
- K212676Osteon Precision Milled Suprastructure2Cleared 510(K)
- K210356Noris Medical Dental Implants System2Cleared 510(K)
- K210826Healing Abutment, Cover Screw2Cleared 510(K)
- K201323INNO SLA Submerged Implant System2Cleared 510(K)
- K213391High Retention Attachment System2Cleared 510(K)
- K212730BellaTek Encode Emergence Healing Abutments2Cleared 510(K)
- K212577DESS Dental Smart Solutions2Cleared 510(K)
- K212664Sherlock2Cleared 510(K)
- K211871FAICO Dental Implant System and CAD/CAM Abutments2Cleared 510(K)
- K213449DS Implants abutments provided with the EV connection2Cleared 510(K)
- K203808Multi-unit Abutment, Multi-unit Angled Abutment2Cleared 510(K)
- K203750Straumann CARES P-Series CAD/CAM System2Cleared 510(K)
- K212108Dynamic TiBase2Cleared 510(K)
- K203649TruAbutment DS, TruBase2Cleared 510(K)
- K210410s-Clean Pre-Milled Abutment Mini2Cleared 510(K)
- K203344Premilled Titanium Block System2Cleared 510(K)
- K210362s-Clean Pre-Milled Abutment2Cleared 510(K)
- K200193Kisses Plus Implant System2Cleared 510(K)
- K203464DESS Dental Smart Solutions2Cleared 510(K)
- K203542Neodent Implant System - Mini Abutment 60°2Cleared 510(K)
- K211225MIS Ti-base abutment2Cleared 510(K)
- K210903IS Multi Unit Abutment System2Cleared 510(K)
- K202579TruAbutment DS, TruBase2Cleared 510(K)
- K203456Straumann CARES M-Series CAD/CAM System2Cleared 510(K)
- K201842TruBase S2Cleared 510(K)
- K203240AccelX Abutments2Cleared 510(K)
- K202909CreoDent Solidex Customized Abutment2Cleared 510(K)
- K201197TruAbutment DS, TruBase S2Cleared 510(K)
- K201681Straumann Immediate Temporary Abutments2Cleared 510(K)
- K203252Multi-unit Abutments for CONELOG2Cleared 510(K)
- K201860Elos Accurate Hybrid Base2Cleared 510(K)
- K203355Straumann TLX Novaloc and Cementable Abutments2Cleared 510(K)
- K192742Straumann Variobase C2Cleared 510(K)
- K202282Neodent Implant System - Zirconia Implant System2Cleared 510(K)
- K202026Blue Sky Bio CAD-CAM Abutments2Cleared 510(K)
- K202095CreoDent Solidex Customized Abutment and Screw2Cleared 510(K)
- K201711CARES Screw - Retained Bars and Bridges (SRBB)2Cleared 510(K)
- K202452NobelProcera Zirconia Implant Bridge2Cleared 510(K)
- K202418Magic UCLA Abutment System2Cleared 510(K)
- K202269PRE-MILLED Abutment2Cleared 510(K)
- K193193Telio CAD Abutment Solutions- extra systems2Cleared 510(K)
- K193084TIB Abutment System2Cleared 510(K)
- K200827LOCATOR R-Tx2Cleared 510(K)
- K200597Straumann BLX Gold Abutments2Cleared 510(K)
- K193408Sirona Dental CAD/CAM System with CEREC Chairside Software2Cleared 510(K)
- K193046Straumann® Retentive System – Novaloc TiN Abutments2Cleared 510(K)
- K200355Duranext Abutments2Cleared 510(K)
- K201621Magicore II System2Cleared 510(K)
- K191152MIS Ti-base Abutment2Cleared 510(K)
- K191913TruAbutment DS2Cleared 510(K)
- K200753IBS Implant System II2Cleared 510(K)
- K193404UF(II) Bar holder abutment2Cleared 510(K)
- K192218Custom Legacy and Custom InterActive Titanium Abutments2Cleared 510(K)
- K192108Panthera Dental Milled Bars2Cleared 510(K)
- K192401Straumann Screw-Retained Abutments2Cleared 510(K)
- K200040Universal Base Conical Connection (CC)2Cleared 510(K)
- K193078MIS CONNECT Conical Connection System2Cleared 510(K)
- K193335Sherlock2Cleared 510(K)
- K193425Pre-Milled Blank2Cleared 510(K)
- K193529ATLANTIS Abutment for MIS Conical Connection Implants2Cleared 510(K)
- K193064Atlantis suprastructures2Cleared 510(K)
- K193274Rodo Abutment System2Cleared 510(K)
- K200189Luna Dental Implant System- Healing Abutment2Cleared 510(K)
- K192263UCLA CCM Abutment2Cleared 510(K)
- K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment2Cleared 510(K)
- K191919Elos Accurate Hybrid Base2Cleared 510(K)
- K191890Elos Accurate Customized Abutment2Cleared 510(K)
- K183106TruAbutment DS2Cleared 510(K)
- K192436Healing Abutments and Cover Screws2Cleared 510(K)
- K191123Multi-unit Abutments2Cleared 510(K)
- K192893Straumann Ceramic Healing Abutments2Cleared 510(K)
- K192457Elos Accurate Customized Abutment2Cleared 510(K)
- K192229Neodent Implant System- GM Titanium Base for Bridge2Cleared 510(K)
- K192522TSV BellaTek Express and BellaTek Flex Abutments2Cleared 510(K)
- K191250Southern Implants PEEK Abutments2Cleared 510(K)
- K191191Neodent Implant System - Temporary Abutments2Cleared 510(K)
- K191986DESS Dental Smart Solutions2Cleared 510(K)
- K191634Scan Abutments and Comfort Caps2Cleared 510(K)
- K192029Straumann PUREloc abutments2Cleared 510(K)
- K191458Legacy SMARTBase Abutments2Cleared 510(K)
- K190048UF(II) Anatomic abutment2Cleared 510(K)
- K191382IPS e.max CAD Abutment Solutions- extra systems2Cleared 510(K)
- K190491Blue Sky Bio Zygomatic Implant System2Cleared 510(K)
- K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV2Cleared 510(K)
- K182455A.B. DENTAL DEVICES Dental Implants System2Cleared 510(K)
- K182091Osstem Abutment System2Cleared 510(K)
- K183079Conometric Abutments2Cleared 510(K)
- K183138Certain BellaTek Express and BellaTek Flex Abutments2Cleared 510(K)
- K190654Straumann CI RD Ceramic Healing Caps2Cleared 510(K)
- K190299Elos Accurate® Customized Abutment2Cleared 510(K)
- K190097Straumann CARES Screw-Retained Bridges and Bars2Cleared 510(K)
- K183580Panthera Dental Milled Bars2Cleared 510(K)
- K173570SD Abutment2Cleared 510(K)
- K190082Straumann BLX Variobase Abutment2Cleared 510(K)
- K182246MIST IC2Cleared 510(K)
- K190040Straumann BLX Line Extension - New Abutments2Cleared 510(K)
- K183518Preat Abutments2Cleared 510(K)
- K181580Cortex CAD/CAM Abutments2Cleared 510(K)
- K182228MIS LOCKiT Abutments System, OT-Equators and Ball Attachments2Cleared 510(K)
- K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases2Cleared 510(K)
- K181037DIO CAD/CAM Abutment2Cleared 510(K)
- K181869On1 Universal Abutment2Cleared 510(K)
- K181381A.B. Dental Devices Dental Implants System2Cleared 510(K)
- K180184Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System2Cleared 510(K)
- K180899Universal Base Abutment2Cleared 510(K)
- K181520Sirona Dental CAD/CAM System2Cleared 510(K)
- K173945Straumann SC Variobase Abutments2Cleared 510(K)
- K180998BioHorizons CAD/CAM Bars2Cleared 510(K)
- K171532TruBase S2Cleared 510(K)
- K181359InterActive SMARTBase Abutments2Cleared 510(K)
- K181189ATLANTIS Conus Structure2Cleared 510(K)
- K173968Straumann Variobase for Bridge/Bar Cylindrical2Cleared 510(K)
- K173908DESS Dental Smart Solutions2Cleared 510(K)
- K180609Rodo Smilekey2Cleared 510(K)
- K172430ArgenIS Titanium Abutments2Cleared 510(K)
- K172640Dentium Implantium & SuperLine Prosthetics2Cleared 510(K)
- K1620213.0 Dynamic TiBase2Cleared 510(K)
- K173902Neodent Implant System – GM Line2Cleared 510(K)
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- K171466NobelDesign, DTX Studio Design2Cleared 510(K)
- K171757Straumann Screw Retained Abutments2Cleared 510(K)
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- K171142Healing Cap Multi-Unit Titanium2Cleared 510(K)
- K171922Anatotemp Anatomic Dental Implant Healing Abutment2Cleared 510(K)
- K162848Straumann CARES Golden Ti/TiN Abutments2Cleared 510(K)
- K170013Eztetic BellaTek Encode Healing Abutments2Cleared 510(K)
- K170838Medentika CAD/CAM TiBases2Cleared 510(K)
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- K163398ATLANTIS suprastructures2Cleared 510(K)
- K170588DESS Dental Smart Solutions2Cleared 510(K)
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- K161689OSSTEM Implant System - Abutment2Cleared 510(K)
- K162734CreoDent Solidex Customized Abutment2Cleared 510(K)
- K160670ET US SS Prosthetic system2Cleared 510(K)
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- K162028PREMIUM - SHELTA Prosthetic Components2Cleared 510(K)
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- K161655On1 Concept2Cleared 510(K)
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- K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC2Cleared 510(K)
- K160979Inclusive Abutments2Cleared 510(K)
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- K161677Straumann Sterile Healing Solution2Cleared 510(K)
- K160436CreoDent Solidex Custom Abutment2Cleared 510(K)
- K160207ATLANTIS ISUS Implant Suprastructures2Cleared 510(K)
- K160964Neodent Implant System - Titanium Base for CEREC2Cleared 510(K)
- K160828Dentium Implantium & SuperLine Prosthetics2Cleared 510(K)
- K160784CAM Titanium Blanks2Cleared 510(K)
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- K160158NobelProcera HT ML FCZ Implant Bridge and Framework2Cleared 510(K)
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- K153036NobelDesign Software2Cleared 510(K)
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- K151039ATLANTIS Abutment for NobelActive 3.02Cleared 510(K)
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- K141970DIGITEK TITANIUM ABUTMENT2Cleared 510(K)
- K150295LOCATOR RTx2Cleared 510(K)
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- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit2Cleared 510(K)
- K141923INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X2Cleared 510(K)
- K142407Straight Stud Attachment2Cleared 510(K)
- K142118INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE2Cleared 510(K)
- K142115INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT2Cleared 510(K)
- K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS2Cleared 510(K)
- K141544ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM2Cleared 510(K)
- K141211INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS2Cleared 510(K)
- K140600SB ANCHOR2Cleared 510(K)
- K140507HIOSSEN PROSTHETIC SYSTEM2Cleared 510(K)
- K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGE2Cleared 510(K)
- K141871Straumann Bone Level NC Angled Screw Retained Abutments2Cleared 510(K)
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- K131468DENRACLE DENTAL ABUTMENT2Cleared 510(K)
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- K133791ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]2Cleared 510(K)
- K133377NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE2Cleared 510(K)
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- K132746NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION2Cleared 510(K)
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- K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES2Cleared 510(K)
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- K132209IPS E.MAX CAD ABUTMENT SOLUTIONS2Cleared 510(K)
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- K130183SFI BAR ABUTMENTS2Cleared 510(K)
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- K130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT2Cleared 510(K)
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- K130310CERTAIN BELLATEK PROVISIONAL ABUTMENTS2Cleared 510(K)
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- K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST2Cleared 510(K)
- K121117NDX ABUTMENTS2Cleared 510(K)
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- K111421SIRONA DENTAL CAD/CAM SYSTEM2Cleared 510(K)
- K112099CONTOUR HEALER2Cleared 510(K)
- K112333LRT ATTACHMENT2Cleared 510(K)
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- K112045SIMPLELINE II ABUTMENT SYSTEM2Cleared 510(K)
- K113092ZIMMER CONTOUR PROVISIONAL COPING2Cleared 510(K)
- K113410NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT2Cleared 510(K)
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- K113283NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS2Cleared 510(K)
- K111853ANGLED TAPERED ABUTMENT2Cleared 510(K)
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- K112259NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS2Cleared 510(K)
- K110308PROSTHETIC SYSTEM2Cleared 510(K)
- K111390SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..2Cleared 510(K)
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- K110580NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS2Cleared 510(K)
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- K110778BIODENTA CUSTOMIZED ABUTMENT2Cleared 510(K)
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- K110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT2Cleared 510(K)
- K102804SPI TITANIUM BASE FOR CAD/CAM2Cleared 510(K)
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- K102467UTA AND UHA2Cleared 510(K)
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- K101607BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS2Cleared 510(K)
- K101608BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS2Cleared 510(K)
- K103280BHDENTAL IMPLANT SYSTEM2Cleared 510(K)
- K103020ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT2Cleared 510(K)
- K101890BALL ABUTMENT SYSTEM2Cleared 510(K)
- K103252CAMLOG VARIO SR ABUTMENTS2Cleared 510(K)
- K100993INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS2Cleared 510(K)
- K101465STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR2Cleared 510(K)
- K102382SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT2Cleared 510(K)
- K102209ENCODE PATIENT SPECIFIC ABUTMENT2Cleared 510(K)
- K101582CAM STRUCTSURE BARS2Cleared 510(K)
- K100152SIRONA CAD/CAM SYSTEM2Cleared 510(K)
- K100356TDS PRECISION DENTAL BAR2Cleared 510(K)
- K100985BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK2Cleared 510(K)
- K101714NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS2Cleared 510(K)
- K101068ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS2Cleared 510(K)
- K101798SPI VARIOMULTI ANGLED ABUTMENT2Cleared 510(K)
- K100245HS/HG PROSTHETIC SYSTEM2Cleared 510(K)
- K101004ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT2Cleared 510(K)
- K093643MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS2Cleared 510(K)
- K090081TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS2Cleared 510(K)
- K093975SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S190092Cleared 510(K)
- K093780ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT2Cleared 510(K)
- K092857VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS2Cleared 510(K)
- K083876SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT2Cleared 510(K)
- K093483ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT2Cleared 510(K)
- K091701STRAUMANN MODIFIED DENTAL ABUTMENT2Cleared 510(K)
- K093113ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT2Cleared 510(K)
- K092814STRAUMANN DENTAL ABUTMENTS2Cleared 510(K)
- K092341LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION2Cleared 510(K)
- K092377PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S2Cleared 510(K)
- K092403TI PREPABLE ABUTMENT, MODEL 1618, 1619, 16202Cleared 510(K)
- K091848NOBEL/PROCERA IMPLANT BRIDGE2Cleared 510(K)
- K091907NOBELPROCERA IMPLANT BRIDGE ZIRCONIA2Cleared 510(K)
- K091920ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL2Cleared 510(K)
- K092248SPI CUSTOMIZABLE GINGIVA FORMER2Cleared 510(K)
- K091904NOBELPROCERA ZI ABUTMENT2Cleared 510(K)
- K091756NOBELPROCERA TI ABUTMENT2Cleared 510(K)
- K091693TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK2Cleared 510(K)
- K091392TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK2Cleared 510(K)
- K090976VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS2Cleared 510(K)
- K091026TDS ABUTMENT FOR NOBEL BIOCARE REPLACE2Cleared 510(K)
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- K090069PROCERA IMPLANT BRIDGE OVERDENTURE2Cleared 510(K)
- K083480INCLUSIVE ZIRCONIA ABUTMENT BLANKS2Cleared 510(K)
- K083871ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE2Cleared 510(K)
- K090723HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,2Cleared 510(K)
- K090153SPI VARIOMULTI ANGLED ABUTMENT2Cleared 510(K)
- K083192INCLUSIVE TITANIUM ABUTMENT BLANKS2Cleared 510(K)
- K081851NEOSS ACCESS ABUTMENTS2Cleared 510(K)
- K083324LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM2Cleared 510(K)
- K083544KAT IMPLANT SYSTEM2Cleared 510(K)
- K081396SWISSPLANT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K081101SPECTRA-SYSTEM ABUTMENTS 20082Cleared 510(K)
- K083474ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT2Cleared 510(K)
- K081786ZIOCERA & CONVERTIBLE SYSTEM2Cleared 510(K)
- K081460TDS ABUTMENT2Cleared 510(K)
- K082299VERICORE IMPLANT ABUTMENTS2Cleared 510(K)
- K083100GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP2Cleared 510(K)
- K083141SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
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- K082764STRAUMANN WN CARES TITANIUM ABUTMENT2Cleared 510(K)
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- K023631ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS2Cleared 510(K)
- K022795MODIFICATION TO THE MAESTRO SYSTEM2Cleared 510(K)
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- K014175SULZER DENTAL CERAMIC SYSTEM-HEXLOCK2Cleared 510(K)
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- 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
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PREMIUM Implant Systems SHELTA Implant Systems
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K161989
- 510(k) Type
- Traditional
- Applicant
- Sweden & Martina S.P.A.
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/1/2018
- Days to Decision
- 562 days
- Submission Type
- Statement