510(k) Report

Devices descending from K081575

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220517IBS SystemInnobiosurg Co., Ltd.20220—
+4K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+4K210039CORE1 Implant SystemCybermed, Inc.20220—
+4K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+4K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+4K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+4K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+4K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+4K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+4K170259TruAbutment DSTruabutment201717—
+4K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+5K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+5K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+5K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+5K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+5K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+5K191913TruAbutment DSTruabutment, Inc.20200—
+5K172304TruAbutment DSTruabutment, Inc.20188—
+6K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+6K201842TruBase STruabutment, Inc.20210—
+6K183106TruAbutment DSTruabutment, Inc.20207—
+7K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+8K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+8K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—