510(k) Report

Devices descending from K063286

211 later devices reach Osseotite; Osseotite NT; XP; TG Osseotite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K142426EBI External Implant SystemEbi, Inc.20150—
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+1K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+1K120414Osseospeed PlusAstra Tech AB2012196—
+1K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+1K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+1K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+2K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K211872PiezoImplant SystemRex Implants, Inc.20220—
+2K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K213599SuperLineDentium Co., Ltd.20220—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+2K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+2K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K171795Thommen Implant SystemThommen Medical AG20170—
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K160786RODO Abutment SystemRodo Medical, Inc.20162—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K160244VARIOuniteThommen Medical AG201615—
+2K1505713i T3 Short ImplantsBiomet 3i20151—
+2K150295LOCATOR RTxZest Anchors, Inc.201542—
+2K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+2K133991ISYAltatec GmbH20142—
+2K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+2K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+2K122300T3 Dental ImplantBiomet 3i2013223
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+3K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+3K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K220823Preat AbutmentsPreat Corporation202216
+3K221966Dynamic TiBaseTalladium Espana, SL20225—
+3K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+3K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—