510(k) Report

Devices descending from K063495

6 later devices reach C Type, CT Type, and Special Type Orthodontic Anchor Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222245ACR Screw SystemBiomaterials Korea, Inc.20230—
+1K202691Ortholock Anchorage DevicesCraniofacial Technologies, Inc.20220—
+1K161335Dual Top Screw SystemJeil Medical Corporation20173—
+2K231913T-FITTechwin Co., Ltd.20240—
+2K210559ATOZ Mini-ScrewMk Meditech, Inc.20210—
+2K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd.20200—