510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+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
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K201712Z5-TLZ-Systems AG20200—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+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—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+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—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K190243Z5-BLZ-Systems AG20202—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.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—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K142260NobelActiveNobel Biocare AB201599—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+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—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—