510(k) Report

Devices descending from K090237

38 later devices reach HG II Fixture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123471Etii SA Fixture SystemHiossen, Inc.201314—
+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—
+2K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+2K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.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—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+3K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K240977DenQ Sub SLA Implant SystemDenq20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—