510(k) Report

Devices descending from K072642

256 later devices reach Biomet 3I Dental Abutments and Restorative Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+1K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+1K170013Eztetic BellaTek Encode Healing AbutmentsBiomet 3i20173—
+1K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+1K130310Certain Bellatek Provisional AbutmentsBiomet 3i20130—
+1K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+1K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+1K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+1K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+1K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+1K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+1K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+2K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+2K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+2K173701Implant-One SystemImplant Logistics, Inc.20181—
+2K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+2K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+2K173374TSV BellaTek Encode Healing AbutmentsBiomet 3i20172—
+2K1514553Shape Abutment Designer Software3Shape A/S201610—
+2K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+2K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+2K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+2K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+2K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+2K133991ISYAltatec GmbH20142—
+2K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+2K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+3K232383iPhysio® SystemEuroteknika20250—
+3K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+3K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+3K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+3K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+3K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K212730BellaTek Encode Emergence Healing AbutmentsBiomet 3i, LLC20210—
+3K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K193352AbutmentCADExocad GmbH20210—
+3K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K200100Abutment Design3Shape A/S20203—
+3K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+3K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+3K191152MIS Ti-base AbutmentDentsply Sirona20201—
+3K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K181932DTX Studio designNobel Biocare AB20190—
+3K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K162390ET Hybrid AbutmentHiossen, Inc.20172—
+3K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233389EK Digital AbutmentsHiossen, Inc.20240—
+4K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+4K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K221107TRUSTRgorithm Korea20230—
+4K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K211225MIS Ti-base abutmentDentsply Sirona20210—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—