510(k) Report

Devices descending from K153521

10 later devices reach IH Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222707IH Implant SystemSewonmedix, Inc.20231—
+1K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+2K240977DenQ Sub SLA Implant SystemDenq20240—
+2K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—