510(k) Report

Devices descending from K894595

1,051 later devices reach Bonefit R Screw Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K220978TSX ImplantsBiomet 3i, LLC20221—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180184Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K173575OsteoReady Dental Implant SystemOsteoready, LLC20180—
+4K180598UNIQA Dental Implants SystemUniqa Dental, Ltd.20181—
+4K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K170131TAV Medical Dental Implants SystemTav Medical, Ltd.20181—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants20170—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K161593GMI Frontier Dental Implant SystemIlerimplant S.L20170—
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+4K152385Zeramex P6 Dental Implant SystemDentalpoint AG20161—
+4K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+4K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+4K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142426EBI External Implant SystemEbi, Inc.20150—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+4K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+4K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+4K122300T3 Dental ImplantBiomet 3i2013223
+4K121098Hero I Dental Implant SystemKj Meditech Co., Ltd.20130—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—