510(k) Report

Devices descending from K020133

334 later devices reach Modification to the Maestro System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191201EM SA Implant SystemHiossen, Inc.20191—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+6K121117NDX AbutmentsNational Dentex Corp20120—
+7K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+7K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+7K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K242379LL Implant SystemOssvis Co., Ltd.20240—
+7K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+7K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+7K182246Mist ICImagine Milling Technologies, LLC20194—
+7K183518Preat AbutmentsPreat Corporation2019223
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+7K171795Thommen Implant SystemThommen Medical AG20170—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+8K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+8K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+8K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+8K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+8K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+8K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+8K222368Mist ICImagine Milling Technologies, LLC20222—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+8K220823Preat AbutmentsPreat Corporation202216
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+8K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+8K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+8K193335SherlockOpen Implants, LLC20203—
+8K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—