510(k) Report

Devices descending from K915375

325 later devices reach Odontit Osseointegrated Implants System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+1K980620Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd.1998322—
+1K980442Crystal and Crystal-Seal Implants SystemCrystal Medical Technology19981—
+2K034067Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc.20040—
+2K0306143I Dental ImplantsImplant Innovations, Inc.2003319—
+2K021915Transitional ImplantsIntra-Lock International20020—
+3K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+3K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+3K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+4K122300T3 Dental ImplantBiomet 3i2013223
+4K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+4K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+4K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+4K072363Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc.200835—
+4K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200720910
+4K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+4K062432Nanotite Dental ImplantsImplant Innovations, Inc.200759—
+4K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+5K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K142426EBI External Implant SystemEbi, Inc.20150—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+5K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+5K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+5K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+5K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+5K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+5K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+6K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K200102MIS Dental Implant SystemDentsply Sirona20200—
+6K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K183518Preat AbutmentsPreat Corporation2019223