510(k) Report

Devices descending from K120951

14 later devices reach Smartbuilder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+1K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+1K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+1K140600SB AnchorOsstem Implant Co., Ltd.20144—
+1K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+2K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+2K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+2K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+2K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K222451Save GBRDentis Co., Ltd.20230—
+2K192747Yxoss CBR®Reoss GmbH20200—
+2K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—