510(k) Report

Devices descending from K123627

21 later devices reach ET Smartfit Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+1K233389EK Digital AbutmentsHiossen, Inc.20240—
+1K152559TruAbutment DSTruabutment201618—
+2K170259TruAbutment DSTruabutment201717—
+3K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+3K191913TruAbutment DSTruabutment, Inc.20200—
+3K172304TruAbutment DSTruabutment, Inc.20188—
+4K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+4K201842TruBase STruabutment, Inc.20210—
+4K183106TruAbutment DSTruabutment, Inc.20207—
+5K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—