510(k) Report

Devices descending from K061003

507 later devices reach SFB & CFB Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—