510(k) Report

Devices descending from K040807

218 later devices reach Mis Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K200386Z5-BLZ-Systems AG20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193335SherlockOpen Implants, LLC20203—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+8K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—