510(k) Report

Devices descending from K053384

528 later devices reach Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+8K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+9K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+9K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+9K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+9K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K220517IBS SystemInnobiosurg Co., Ltd.20220—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+9K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+10K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—