510(k) Report

Devices descending from K152110

4 later devices reach e-1 etchants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172953Acid EtchantAmerican Orthodontics20183—
+2K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc.20220—
+2K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International20201—
+3K210421Diafil & Diafil CapsuleDiaDent Group International20210—