510(k) Report

Devices descending from K082545

171 later devices reach Straumann NN Cares Titanium and Ceramic Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220823Preat AbutmentsPreat Corporation202216
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220482SherlockOpen Implants, LLC20221—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K243732Multi-Unit DAS SystemTalladium España, SL20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K243530Dynamic TiBaseTalladium España, SL20250—
+10K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+10K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—