510(k) Report

Devices descending from K063341

209 later devices reach 3I Osseotite Certain Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K160119NobelSpeedy GroovyNobel Biocare AB20167—
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+1K140934Hiossen Implant SystemHiossen, Inc.201413—
+1K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+1K122300T3 Dental ImplantBiomet 3i2013223
+1K113779Conelog Implant SystemAltatec GmbH201214—
+1K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+1K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+1K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+1K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+1K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+2K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+2K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+2K200102MIS Dental Implant SystemDentsply Sirona20200—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K173701Implant-One SystemImplant Logistics, Inc.20181—
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+2K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+2K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+2K153779Abutment for BridgesAltatec GmbH20161—
+2K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+2K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+2K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+2K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+2K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+2K133991ISYAltatec GmbH20142—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+2K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+2K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+2K082749Omni-TightBasic Dental Implant Systems, Inc.20080—
+3K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+3K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+3K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+3K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+3K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K220823Preat AbutmentsPreat Corporation202216
+3K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+3K211872PiezoImplant SystemRex Implants, Inc.20220—