510(k) Report

Devices descending from K012757

535 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K221107TRUSTRgorithm Korea20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+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—
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—