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
- 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)
- K170354Straumann Variobase Abutments2Cleared 510(K)
- K170356Straumann 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)
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- K162028PREMIUM - SHELTA Prosthetic Components2Cleared 510(K)
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- K162004PREMIUM Implant Systems SHELTA Implant Systems2Cleared 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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- K161030ATLANTIS Abutment for CONELOG implant2Cleared 510(K)
- K153509GPS Angled Abutment2Cleared 510(K)
- K160382OT EQUATOR2Cleared 510(K)
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- 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)
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- K153624Neodent Implant System2Cleared 510(K)
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- K151439ATLANTIS ISUS2Cleared 510(K)
- K151194KLOCKNER DENTAL IMPLANT ABUTMENTS (II)2Cleared 510(K)
- K151039ATLANTIS Abutment for NobelActive 3.02Cleared 510(K)
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- K142211OT EQUATOR2Cleared 510(K)
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- K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)2Cleared 510(K)
- K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant System2Cleared 510(K)
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- K143051ArgenIS Titanium Abutments2Cleared 510(K)
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- K142115INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT2Cleared 510(K)
- K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS2Cleared 510(K)
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- K140600SB ANCHOR2Cleared 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)
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- 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)
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- K132209IPS E.MAX CAD ABUTMENT SOLUTIONS2Cleared 510(K)
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- 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)
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- K123627ET SMARTFIT ABUTMENT2Cleared 510(K)
- K130310CERTAIN BELLATEK PROVISIONAL ABUTMENTS2Cleared 510(K)
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- K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT2Cleared 510(K)
- K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS2Cleared 510(K)
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- K123755MULTI ANGLED ABUTMENT2Cleared 510(K)
- K124008IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE2Cleared 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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- K111935TI-BASE ABUTMENT, 1 CONNECT ABUTMENT2Cleared 510(K)
- 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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- K112280STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM2Cleared 510(K)
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- 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)
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- K110580NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS2Cleared 510(K)
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- K110171NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS2Cleared 510(K)
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- K101608BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS2Cleared 510(K)
- K103280BHDENTAL IMPLANT SYSTEM2Cleared 510(K)
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- 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)
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- 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)
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- 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)
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- K093780ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT2Cleared 510(K)
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- 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)
- 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)
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- 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)
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- K032498DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)2Cleared 510(K)
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- K031747SPI DENTAL IMPLANT ABUTMENTS2Cleared 510(K)
- K031719ESTHETIC ZIRCONIA ABUTMENT2Cleared 510(K)
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- K023631ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS2Cleared 510(K)
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- K925769BRANEMARK SYSTEM ABUTMENTS COMPLETE2Cleared 510(K)
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- 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
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VARIOunite
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K160244
- 510(k) Type
- Traditional
- Applicant
- Thommen Medical AG
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/2/2016
- Days to Decision
- 122 days
- Submission Type
- Summary