510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K150295LOCATOR RTxZest Anchors, Inc.201542—
+7K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+7K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K260940BellaTek BarsZimVie US Corp, LLC20260—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+8K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+8K180609Rodo SmilekeyRodo Medical, Inc.20180—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K170394Kisses MiniAchimhai Medical Corporation20170—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+8K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+8K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+8K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+9K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K213391High Retention Attachment SystemZest Anchors, LLC20227—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+9K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+9K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K220252High Retention Attachment SystemZest Anchors, LLC20221—
+10K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+11K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+11K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+12K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+12K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—