510(k) Report

Devices descending from K063364

187 later devices reach Alpha Bio Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220482SherlockOpen Implants, LLC20221—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K243732Multi-Unit DAS SystemTalladium España, SL20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K243530Dynamic TiBaseTalladium España, SL20250—
+10K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—