510(k) Report

Devices descending from K100245

111 later devices reach HS/HG Prosthetic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+6K201842TruBase STruabutment, Inc.20210—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K183106TruAbutment DSTruabutment, Inc.20207—
+7K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+8K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+8K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+9K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—