510(k) Report

Devices descending from K230237

1 later device reach Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—