510(k) Report

Devices descending from K091026

43 later devices reach TDS Abutment for Nobel Biocare Replace through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+1K121117NDX AbutmentsNational Dentex Corp20120—
+1K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+1K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+2K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+2K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+3K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+3K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+3K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+3K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+3K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+3K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+3K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K171795Thommen Implant SystemThommen Medical AG20170—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K220823Preat AbutmentsPreat Corporation202216
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K231566ICX-Implant SystemMedentis Medical GmbH20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K212664SherlockOpen Implants, LLC20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K220482SherlockOpen Implants, LLC20221—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K250967SherlockOpen Implants, LLC20250—