510(k) Report

Devices descending from K071638

129 later devices reach Biohorizons Tapered Internal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K220823Preat AbutmentsPreat Corporation202216
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193335SherlockOpen Implants, LLC20203—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+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—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+8K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K220482SherlockOpen Implants, LLC20221—
+9K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K250967SherlockOpen Implants, LLC20250—