510(k) Report

Devices descending from K080598

128 later devices reach Mini Drive-Lock Dental Implant System Prosthetics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+3K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+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—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243278Custom AbutmentsInstitut Straumann AG202501
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K212664SherlockOpen Implants, LLC20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—