510(k) Report

Devices descending from K033430

213 later devices reach 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+1K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K142426EBI External Implant SystemEbi, Inc.20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+2K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+2K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+2K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+2K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K211872PiezoImplant SystemRex Implants, Inc.20220—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K213599SuperLineDentium Co., Ltd.20220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K160786RODO Abutment SystemRodo Medical, Inc.20162—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K160244VARIOuniteThommen Medical AG201615—
+3K1505713i T3 Short ImplantsBiomet 3i20151—
+3K150295LOCATOR RTxZest Anchors, Inc.201542—
+3K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+3K133991ISYAltatec GmbH20142—
+3K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K122300T3 Dental ImplantBiomet 3i2013223
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220823Preat AbutmentsPreat Corporation202216
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—