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
- 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
- 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)
- K171409OT EQUATOR2Cleared 510(K)
- K173379Straumann Variobase for Crown AS2Cleared 510(K)
- K173326MIS CONNECT Conical Connection Abutment2Cleared 510(K)
- K173120CCM Abutment System2Cleared 510(K)
- K171649Straumann CARES M-Series CAD/CAM System2Cleared 510(K)
- K172160Southern Implants PEEK Abutments2Cleared 510(K)
- K161989PREMIUM Implant Systems SHELTA Implant Systems2Cleared 510(K)
- K173466Panthera Dental Milled Bars2Cleared 510(K)
- K172304TruAbutment DS2Cleared 510(K)
- K171799Elos Accurate Customized Abutment, Elos Prosthetic Screw2Cleared 510(K)
- K171622Dentium Ti-Base2Cleared 510(K)
- K170421ET Hybrid Abutment2Cleared 510(K)
- K172798Straumann CARES Abutments CoCr2Cleared 510(K)
- K172854NobelPerfect Abutments2Cleared 510(K)
- K173374TSV BellaTek Encode Healing Abutments2Cleared 510(K)
- K171773Straumann n!ce Glass Ceramic A14 Blocks2Cleared 510(K)
- K172225Atlantis Abutment for MIS Implant2Cleared 510(K)
- K171694s-Clean TiN Coating Abutments2Cleared 510(K)
- K171466NobelDesign, DTX Studio Design2Cleared 510(K)
- K171757Straumann Screw Retained Abutments2Cleared 510(K)
- K170022Klockner Vega TiBase for CEREC2Cleared 510(K)
- K170080Neodent Implant System - CM Pro PEEK Abutment2Cleared 510(K)
- 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)
- K170384Dentium NR Line CAD/CAM Abutments2Cleared 510(K)
- K163398ATLANTIS suprastructures2Cleared 510(K)
- K170588DESS Dental Smart Solutions2Cleared 510(K)
- K162633Custom Bars2Cleared 510(K)
- K170100CreoDent Solidex Customized Abutment and Screw2Cleared 510(K)
- K170356Straumann Variobase Abutments2Cleared 510(K)
- K170354Straumann Variobase Abutments2Cleared 510(K)
- K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System2Cleared 510(K)
- K170259TruAbutment DS2Cleared 510(K)
- K161689OSSTEM Implant System - Abutment2Cleared 510(K)
- K162734CreoDent Solidex Customized Abutment2Cleared 510(K)
- K160670ET US SS Prosthetic system2Cleared 510(K)
- K163350Multibase Abutments EV and ATLANTIS Suprastructures2Cleared 510(K)
- K162028PREMIUM - SHELTA Prosthetic Components2Cleared 510(K)
- K161416Multi-unit Abutment Plus2Cleared 510(K)
- K161655On1 Concept2Cleared 510(K)
- K162390ET Hybrid Abutment2Cleared 510(K)
- K161713Dentium CAD/CAM Abutments2Cleared 510(K)
- K160798IPS e.max® Press Abutment Solutions for Viteo Base Ti2Cleared 510(K)
- K162004PREMIUM Implant Systems SHELTA Implant Systems2Cleared 510(K)
- K153015Transfer & Angled Abutment2Cleared 510(K)
- K161435Temporary Snap Abutment2Cleared 510(K)
- K160786RODO Abutment System2Cleared 510(K)
- K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC2Cleared 510(K)
- K160979Inclusive Abutments2Cleared 510(K)
- K160519Link Abutment for CEREC2Cleared 510(K)
- 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)
- K160626ATLANTIS Abutment for HIOSSEN ET implant2Cleared 510(K)
- K161030ATLANTIS Abutment for CONELOG implant2Cleared 510(K)
- K153509GPS Angled Abutment2Cleared 510(K)
- K160382OT EQUATOR2Cleared 510(K)
- K160483Burn-out Cylinder and Angled Screw Abutments2Cleared 510(K)
- K160248ArgenIS Titanium Abutments2Cleared 510(K)
- K160158NobelProcera HT ML FCZ Implant Bridge and Framework2Cleared 510(K)
- K153645VITA ENAMIC Implant Solutions (IS)2Cleared 510(K)
- K160244VARIOunite2Cleared 510(K)
- K153036NobelDesign Software2Cleared 510(K)
- K152559TruAbutment DS2Cleared 510(K)
- K153624Neodent Implant System2Cleared 510(K)
- K1516084plus6Line Abutment System2Cleared 510(K)
- K153779Abutment for Bridges2Cleared 510(K)
- K152845Allied Biocompat Abutment for Nobel Replace Interface2Cleared 510(K)
- K151984Thommen Milling Abutment for CAD/CAM2Cleared 510(K)
- K151789LOCATOR F-Tx Attachment System2Cleared 510(K)
- K151590Straumann RN Gold Abutment for Bridge2Cleared 510(K)
- K151439ATLANTIS ISUS2Cleared 510(K)
- K151194KLOCKNER DENTAL IMPLANT ABUTMENTS (II)2Cleared 510(K)
- K151039ATLANTIS Abutment for NobelActive 3.02Cleared 510(K)
- K151621BioHorizons CAD/CAM Abutments2Cleared 510(K)
- K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)2Cleared 510(K)
- K151295Biodenta Customized Abutment - Titanium2Cleared 510(K)
- K142211OT EQUATOR2Cleared 510(K)
- K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System2Cleared 510(K)
- K151432NaturalLine Abutment2Cleared 510(K)
- K150203Medentika CAD/CAM Abutments2Cleared 510(K)
- K151169OsteoReady ZircoSeal Abutments2Cleared 510(K)
- K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)2Cleared 510(K)
- K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant System2Cleared 510(K)
- K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants2Cleared 510(K)
- K151564Telio CAD Abutment Solutions2Cleared 510(K)
- K150899Straumann CARES Titanium Alloy (TAN) Abutment2Cleared 510(K)
- K143051ArgenIS Titanium Abutments2Cleared 510(K)
- K151324Straumann Variobase for CEREC2Cleared 510(K)
- K151247NC Straumann Screw Retained Abutments2Cleared 510(K)
- K150814Straumann Screw-Retained Abutment2Cleared 510(K)
- K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges2Cleared 510(K)
- K141970DIGITEK TITANIUM ABUTMENT2Cleared 510(K)
- K150295LOCATOR RTx2Cleared 510(K)
- K150367Neodent Implant System2Cleared 510(K)
- K150296Biodenta Customized Abutment-Hybrid2Cleared 510(K)
- K143505Zimmer Patient-Specific Abutment, Internal Hex, Titanium2Cleared 510(K)
- K150250SternSnap Angled Attachment2Cleared 510(K)
- K150012CreoDent Solidex Customized Abutment2Cleared 510(K)
- K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System2Cleared 510(K)
- K142167MEDENTIKA ABUTMENT SYSTEM2Cleared 510(K)
- K143337CONELOG Titanium base CAD/CAM2Cleared 510(K)
- K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System2Cleared 510(K)
- 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)
- K141120ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM2Cleared 510(K)
- K132749NOBELPROCERA OVERDENTURE BAR2Cleared 510(K)
- K133551ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM2Cleared 510(K)
- K132214ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE2Cleared 510(K)
- K131468DENRACLE DENTAL ABUTMENT2Cleared 510(K)
- K134045ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM2Cleared 510(K)
- K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW2Cleared 510(K)
- 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)
- K130618SFI-ANCHOR2Cleared 510(K)
- K133696NEODENT IMPLANT SYSTEM2Cleared 510(K)
- K132814SFI-BAR IMPLANT ABUTMENTS2Cleared 510(K)
- K132219STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,2Cleared 510(K)
- K132746NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION2Cleared 510(K)
- K131644ANKYLOS SYNCONE ABUTMENT 5(DEGREE)2Cleared 510(K)
- K132844STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES2Cleared 510(K)
- K130662ET PROSTHETIC SYSTEM2Cleared 510(K)
- K132067MULTI ANGLED ABUTMENT SYSTEM2Cleared 510(K)
- K132209IPS E.MAX CAD ABUTMENT SOLUTIONS2Cleared 510(K)
- K122295CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS2Cleared 510(K)
- K131526SFI-BAR2Cleared 510(K)
- K113738CREODENT SOLIDEX CUSTOM ABUTMENT2Cleared 510(K)
- K131101ITERO SOFTWARE2Cleared 510(K)
- K122988KLOCKNER DENTAL IMPLANT ABUTMENTS2Cleared 510(K)
- K130183SFI BAR ABUTMENTS2Cleared 510(K)
- K122424ISUS IMPLANT SUPRASTRUCTURES2Cleared 510(K)
- K130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT2Cleared 510(K)
- K130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS2Cleared 510(K)
- K123627ET SMARTFIT ABUTMENT2Cleared 510(K)
- K130310CERTAIN BELLATEK PROVISIONAL ABUTMENTS2Cleared 510(K)
- K120954NOBELPROCERA PEEK ABUTMENTS2Cleared 510(K)
- K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT2Cleared 510(K)
- K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS2Cleared 510(K)
- K130216ATLANTIS STRAUMANN BONE LEVEL ABUTMENT2Cleared 510(K)
- K123755MULTI ANGLED ABUTMENT2Cleared 510(K)
- K124008IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE2Cleared 510(K)
- K122602NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS2Cleared 510(K)
- K113816GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV2Cleared 510(K)
- K121810OSSEOSPEED ANGLED ABUTMENT EV2Cleared 510(K)
- K120822STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST2Cleared 510(K)
- K121117NDX ABUTMENTS2Cleared 510(K)
- K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS2Cleared 510(K)
- K121843NP-CAST ABUTMENT SYSTEM2Cleared 510(K)
- K121391INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS2Cleared 510(K)
- K120858IMPLANT BAR2Cleared 510(K)
- K120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM2Cleared 510(K)
- K122192NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM2Cleared 510(K)
- K121709ZFX DENTAL CAD SYSTEM2Cleared 510(K)
- K120053IPS E.MAX PRESS - ABUTMENT SOLUTIONS2Cleared 510(K)
- K121688MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM2Cleared 510(K)
- K120776ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION2Cleared 510(K)
- K121334VARIOECO2Cleared 510(K)
- K112787KERATOR2Cleared 510(K)
- K120338ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA2Cleared 510(K)
- K113003ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...2Cleared 510(K)
- K111935TI-BASE ABUTMENT, 1 CONNECT ABUTMENT2Cleared 510(K)
- K111421SIRONA DENTAL CAD/CAM SYSTEM2Cleared 510(K)
- K112099CONTOUR HEALER2Cleared 510(K)
- K112333LRT ATTACHMENT2Cleared 510(K)
- K113606NNC GOLD ABUTMENT FOR BRIDGES2Cleared 510(K)
- 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)
- K112730ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION2Cleared 510(K)
- 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)
- K112138ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT2Cleared 510(K)
- K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM2Cleared 510(K)
- K111984SPI VARIO ANGLED ABUTMENT2Cleared 510(K)
- K103291BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE2Cleared 510(K)
- K103691BIOHORIZONS ABUTMENTS FOR ZIMMER2Cleared 510(K)
- 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)
- K110565ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE2Cleared 510(K)
- K110580NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS2Cleared 510(K)
- K111852ANODIZED HEALING COLLAR2Cleared 510(K)
- K111199INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS2Cleared 510(K)
- K110778BIODENTA CUSTOMIZED ABUTMENT2Cleared 510(K)
- K103234GC AADVA BO AC ABUTMENTS2Cleared 510(K)
- K11158115 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE2Cleared 510(K)
- K101005ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT2Cleared 510(K)
- K110171NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS2Cleared 510(K)
- K110640ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT2Cleared 510(K)
- K110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT2Cleared 510(K)
- K102804SPI TITANIUM BASE FOR CAD/CAM2Cleared 510(K)
- K103759ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT2Cleared 510(K)
- K102467UTA AND UHA2Cleared 510(K)
- K103339TDS ABUTMENT FOR FRIADENT XIVE2Cleared 510(K)
- 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)
- K090347CAMLOG ABUTMENTS PS2Cleared 510(K)
- K090397XPI ANGLED ABUTMENTS2Cleared 510(K)
- 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)
- K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS2Cleared 510(K)
- K081666ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS2Cleared 510(K)
- K082764STRAUMANN WN CARES TITANIUM ABUTMENT2Cleared 510(K)
- K080164ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT2Cleared 510(K)
- K081575HU/HS/HG PROSTHETIC SYSTEM2Cleared 510(K)
- K081157ACCUFRAME2Cleared 510(K)
- K080864CAM STRUCTSURE PRECISION MILLED BARS2Cleared 510(K)
- K081186CONCAVE RN HEALING CAP2Cleared 510(K)
- K080598MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS2Cleared 510(K)
- K073217INCLUSIVE IMPLANT ABUTMENTS2Cleared 510(K)
- K080397AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM2Cleared 510(K)
- K081005P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS2Cleared 510(K)
- K080239P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS2Cleared 510(K)
- K072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2Cleared 510(K)
- K080286CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS2Cleared 510(K)
- K073345CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT2Cleared 510(K)
- K073553CAMLOG IMPLANT SYSTEM ABUTMENTS2Cleared 510(K)
- K073540ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT2Cleared 510(K)
- K072055LAVA FRAME, LAVA FRAME SHADE2Cleared 510(K)
- K072129NOBELACTIVE ZIRCONIA ABUTMENT2Cleared 510(K)
- K072856SPI VARIOMULTI ABUTMENT2Cleared 510(K)
- K073258ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT2Cleared 510(K)
- K072100GC AADVA ABUTMENT2Cleared 510(K)
- K073073ANKYLOS TEMPORARY ABUTMENT BALANCE2Cleared 510(K)
- K073628SYNOCTA ABUTMENTS2Cleared 510(K)
- K072570NOBELACTIVE MULTI UNIT ABUTMENT2Cleared 510(K)
- K072642BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS2Cleared 510(K)
- K073141SPI ART ABUTMENT2Cleared 510(K)
- K072878MODIFICATION TO: LOCATOR IMPLANT ANCHOR2Cleared 510(K)
- K070228IMPLANTIUM PROSTHETICS2Cleared 510(K)
- K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS2Cleared 510(K)
- K072483ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS2Cleared 510(K)
- K072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEM2Cleared 510(K)
- K071838NEOSS VARIOUS TITANIUM ABUTMENTS2Cleared 510(K)
- K071888STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES2Cleared 510(K)
- K072679P.004 ABUTMENTS2Cleared 510(K)
- K072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS2Cleared 510(K)
- K071946ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS2Cleared 510(K)
- K072624ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT2Cleared 510(K)
- K072497P.004 NC GOLD ABUTMENT FOR CROWNS2Cleared 510(K)
- K071919P.004 ABUTMENTS2Cleared 510(K)
- K071357P.004 NC ANATOMIC ABUTMENTS2Cleared 510(K)
- K070478P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)2Cleared 510(K)
- K071453SPI EASY 4.0 ABUTMENT2Cleared 510(K)
- K072151P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS2Cleared 510(K)
- K070549STRAUMANN P.004 RC GOLD ABUTMENT2Cleared 510(K)
- K071551QUICKBRIDGE TM CYLINDER AND CAP2Cleared 510(K)
- K072071STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS2Cleared 510(K)
- K071213CAMLOG LOGFIT PROSTHETIC SYSTEM2Cleared 510(K)
- K071585P.004 HEALING ABUTMENTS AND CLOSURE SCREWS2Cleared 510(K)
- K070744NARROW NECK TEMPORARY COPING2Cleared 510(K)
- K063768TITANIUM SCALLOPED ABUTMENT2Cleared 510(K)
- K070833ATLANTIS ABUTMENT FOR ASTRA IMPLANT2Cleared 510(K)
- K070533BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS2Cleared 510(K)
- K063106REVOIS IMPLANT SYSTEM2Cleared 510(K)
- K070562EZ PLUS IMPLANT SYSTEM2Cleared 510(K)
- K063789WN SYNOCTA GOLD ABUTMENT2Cleared 510(K)
- K061277STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING2Cleared 510(K)
- K063403CONICAL ANGLED ABUTMENT2Cleared 510(K)
- K063734ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE2Cleared 510(K)
- K062197ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT2Cleared 510(K)
- K063592ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 345542Cleared 510(K)
- K062069ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT2Cleared 510(K)
- K062277ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE2Cleared 510(K)
- K062749SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM2Cleared 510(K)
- K061567BIOHORIZONS CERAMIC ABUTMENT2Cleared 510(K)
- K062493LAVA SOFTWARE2Cleared 510(K)
- K062876PRIMACONNEX CERAMIC ABUTMENTS2Cleared 510(K)
- K061847ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S2Cleared 510(K)
- K061529PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM2Cleared 510(K)
- K061478PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS2Cleared 510(K)
- K061477MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS2Cleared 510(K)
- K061807SPI ART ABUTMENTS2Cleared 510(K)
- K053654ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE2Cleared 510(K)
- K052957IMPLANTIUM PROSTHETICS2Cleared 510(K)
- K061969PREFORMANCE POSTS AND TEMPORARY CYLINDERS2Cleared 510(K)
- K053373ATLANTIS ABUTMENT FOR ZIMMER INTERFACE2Cleared 510(K)
- K061043ZIMMER CONTOUR RESTORATIVE SYSTEM2Cleared 510(K)
- K060063LEGACY ABUTMENT SYSTEM2Cleared 510(K)
- K060880ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C12Cleared 510(K)
- K061177PROVIDE TEMPORARY CYLINDER2Cleared 510(K)
- K053450ATLANTIS ABUTMENT FOR ZIMMER INTERFACE2Cleared 510(K)
- K060291PREFORMANCE TEMPORARY CYLINDER2Cleared 510(K)
- K053125PROCERA BRIDGE ZIRCONIA2Cleared 510(K)
- K053068PROCERA BRIDGE LAMINATE, MODEL 40-40022Cleared 510(K)
- K053050PROCERA BRIDGE ALUMINA2Cleared 510(K)
- K052823IMPLANTIUM ABUTMENTS2Cleared 510(K)
- K051636CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES2Cleared 510(K)
- K053099BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS2Cleared 510(K)
- K053602PROCERA SOFTWARE, MODEL 331452Cleared 510(K)
- K053170PREFORMANCE POSTS2Cleared 510(K)
- K053091PROCERA IMPLANT BRIDGE ZIRCONIA2Cleared 510(K)
- K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-420262Cleared 510(K)
- K052272STRAUMANN COMPUTER AIDED RESTORATION SERVICE2Cleared 510(K)
- K052885ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 293152Cleared 510(K)
- K052648MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS2Cleared 510(K)
- K051501ZIRACE2Cleared 510(K)
- K052070ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA2Cleared 510(K)
- K052600ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)2Cleared 510(K)
- K051527SPI EASY TEMPORARY CAP2Cleared 510(K)
- K051652ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT2Cleared 510(K)
- K051011ENDOSSEOUS DENTAL IMPLANT ABUTMENT2Cleared 510(K)
- K043428RELIADENT DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K051717RN SYNOCTA TEMPORARY MESO ABUTMENT2Cleared 510(K)
- K050444NOBELREPLACE ADAPTER, MODEL 324122Cleared 510(K)
- K050208FRIADENT ESTHETICAP2Cleared 510(K)
- K050641ZYGOMA TIUNITE2Cleared 510(K)
- K042715TITAN DENTAL IMPLANT ATTACHMENT2Cleared 510(K)
- K050052ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE2Cleared 510(K)
- K043190SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM2Cleared 510(K)
- K042466X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE2Cleared 510(K)
- K043042PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-10522Cleared 510(K)
- K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-60042Cleared 510(K)
- K041070STRAUMANN TEMPORARY COPING2Cleared 510(K)
- K041275PROCERA ABUTMENT OCTAGON2Cleared 510(K)
- K041236PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-10522Cleared 510(K)
- K041295RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT2Cleared 510(K)
- K040573NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 312362Cleared 510(K)
- K0340353I PATIENT-SPECIFIC OVERDENTURE BAR2Cleared 510(K)
- K040205INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS2Cleared 510(K)
- K040539ELLIPTIC MATRIX2Cleared 510(K)
- K033724NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 312362Cleared 510(K)
- K033346SPI EASY DENTAL IMPLANT PROTECTIVE CAP2Cleared 510(K)
- K033243ITI SYNOCTA MESO ABUTMENTS2Cleared 510(K)
- K032498DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)2Cleared 510(K)
- K032448ALTATEC CERAMIC ABUTMENT2Cleared 510(K)
- K031747SPI DENTAL IMPLANT ABUTMENTS2Cleared 510(K)
- K031719ESTHETIC ZIRCONIA ABUTMENT2Cleared 510(K)
- K023645SPI EASY DENTAL IMPLANT ABUTMENT2Cleared 510(K)
- K023631ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS2Cleared 510(K)
- K022795MODIFICATION TO THE MAESTRO SYSTEM2Cleared 510(K)
- K021460OCO DENTAL IMPLANT2Cleared 510(K)
- K014175SULZER DENTAL CERAMIC SYSTEM-HEXLOCK2Cleared 510(K)
- K974150PROCERA PREPARABLE ABUTMENT SYSTEM2Cleared 510(K)
- K972475AURADAPT AUBTMENT SYSTEM2Cleared 510(K)
- K971706TIADAPT ABUTMENT SYSTEM2Cleared 510(K)
- K970073BIO-ESTHETIC INDIRECT ABUTMENT2Cleared 510(K)
- K96173617 ANGULATED ABUTMENT2Cleared 510(K)
- K961728MIRUSCONE ABUTMENT SYSTEM2Cleared 510(K)
- K925349ONE SYSTEM TAPERED TITANIUM ABUTMENTS2Cleared 510(K)
- K925779BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS2Cleared 510(K)
- K925769BRANEMARK SYSTEM ABUTMENTS COMPLETE2Cleared 510(K)
- 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
Custom Legacy and Custom InterActive Titanium Abutments
- Page Type
- Cleared 510(K)
- 510(k) Number
- K192218
- 510(k) Type
- Traditional
- Applicant
- Implant Direct Sybron Manufacturing , LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/8/2020
- Days to Decision
- 267 days
- Submission Type
- Summary