510(k) Report

Devices descending from K981516

1,066 later devices reach Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K052254Mytis Arrow XXXXBrainbase Corporation20060—
+3K053450Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.20062—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K050956TBR Idea Conic/ConicSudimplant SA20062—
+3K052369Exfeel Implant SystemMegagen Co., Ltd.200684—
+3K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+3K040757Sic ProSic Invent AG20052—
+3K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+3K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491—
+3K040946Ankylos Dental Implant SystemFriadent GmbH20043—
+3K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+3K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd.2004218—
+3K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+3K034014Spi Contact Dental ImplantThommen Medical AG20043—
+3K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20043461
+3K032774Renova Internal Hex Implant SystemLifecore Biomedical, Inc.200349—
+3K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200268927
+3K0118793A Dental Implant SystemOsseco Biosource, Ltd.2002223—
+3K013067Frialoc Dental Implant SystemFriadent GmbH2002568—
+4K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K220978TSX ImplantsBiomet 3i, LLC20221—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K201712Z5-TLZ-Systems AG20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200386Z5-BLZ-Systems AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+4K190243Z5-BLZ-Systems AG20202—
+4K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K180184Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG20180—
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K173575OsteoReady Dental Implant SystemOsteoready, LLC20180—
+4K180598UNIQA Dental Implants SystemUniqa Dental, Ltd.20181—
+4K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K170131TAV Medical Dental Implants SystemTav Medical, Ltd.20181—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants20170—
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K161593GMI Frontier Dental Implant SystemIlerimplant S.L20170—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+4K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K152385Zeramex P6 Dental Implant SystemDentalpoint AG20161—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+4K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562