510(k) Report

Devices descending from K033922

346 later devices reach Modification to Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—