510(k) Report

Devices descending from K110392

5 later devices reach PSM Lomas / Benefit Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.20250—
+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—