510(k) Report

Devices descending from K023952

295 later devices reach Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191201EM SA Implant SystemHiossen, Inc.20191—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K190654Straumann CI RD Ceramic Healing CapsInstitut Straumann AG20192—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+7K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+7K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+7K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K242379LL Implant SystemOssvis Co., Ltd.20240—
+7K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+7K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+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—
+7K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+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—
+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—
+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—
+9K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+9K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+9K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+9K243009Mist ICImagine Milling Technologies, LLC20251—
+9K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+9K243824Preat AbutmentsPreat Corporation20250—
+9K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+9K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+9K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+9K212664SherlockOpen Implants, LLC20212—
+9K212108Dynamic TiBaseTalladium España, SL20219—
+9K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+10K261122Mist ICImagine Milling Technologies, LLC20260—
+10K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+10K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+10K221673Bonafix TiBaseZentek Medical, LLC20231—
+10K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+10K221966Dynamic TiBaseTalladium Espana, SL20225—
+10K220482SherlockOpen Implants, LLC20221—
+11K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+11K250967SherlockOpen Implants, LLC20250—
+11K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+11K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+11K231559Multi-Unit DAS SystemTalladium España, SL20231—
+11K232151Dynamic TiBaseTalladium España, SL20232—
+11K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+12K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+12K243732Multi-Unit DAS SystemTalladium España, SL20260—
+12K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+12K243530Dynamic TiBaseTalladium España, SL20250—
+12K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+12K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+13K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+14K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—