510(k) Report

Devices descending from K981516

1,066 later devices reach Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K142260NobelActiveNobel Biocare AB201599—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142426EBI External Implant SystemEbi, Inc.20150—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+4K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+4K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+4K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+4K122300T3 Dental ImplantBiomet 3i2013223
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K121098Hero I Dental Implant SystemKj Meditech Co., Ltd.20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+4K112162Conical Connection ImplantsMis Implants Technologies, Ltd.20122—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+4K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+4K110565Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc.201110—
+4K103790Ace Trimark Tricam Dental ImplantAce Surgical Supply Company, Inc.20110—
+4K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+4K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+4K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+4K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+4K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K090174Tsi; EriOco Biomedical20094—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+4K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+4K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K080713Reactive Dental Implant SystemImplant Direct, LLC200823—
+4K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+4K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+4K072363Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc.200835—
+4K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+4K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+4K070935T.B.R. ZirconnectSudimplant SA20070—
+4K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc.200702
+4K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+4K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+4K061323Modification to Reliadent Dental Implant SystemBioinfera, Inc.20072—
+4K070562EZ Plus Implant SystemMegagen Co., Ltd.200774—
+4K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200720910
+4K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+4K070022Mistral - One Stage Screw-Type Dental Implant, Model MF9Mis Implants Technologies, Ltd.20072—
+4K062432Nanotite Dental ImplantsImplant Innovations, Inc.200759—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K053654Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc.200612—
+4K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+4K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531—
+4K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc.2005405
+4K051576Avana Dental Implant SystemOsstem Co., Ltd.2005222—
+4K050635Allfim Implant SystemsCowellmedi Co., Ltd.20055—