510(k) Report

Devices descending from K091208

28 later devices reach GS Iii System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131165Anker Dental Implant SystemAlliance Global20131—
+1K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+1K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+2K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+2K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+2K222738Point implant systemPointnix Co., Ltd.20230—
+2K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+2K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+2K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+2K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+2K153521IH Implant SystemSewonmedix, Inc.201610—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+3K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+3K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+3K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K222707IH Implant SystemSewonmedix, Inc.20231—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K240977DenQ Sub SLA Implant SystemDenq20240—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—