510(k) Report

Devices descending from K070478

283 later devices reach P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K221966Dynamic TiBaseTalladium Espana, SL20225—
+9K220482SherlockOpen Implants, LLC20221—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+10K231559Multi-Unit DAS SystemTalladium España, SL20231—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+10K201842TruBase STruabutment, Inc.20210—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+12K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+12K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+13K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—