510(k) Report

Devices descending from K112597

3 later devices reach Seity 37% Phosphoric Acid Etchant Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International20201—
+1K150696Jade 37% Phosphoric Acid Etchant GelDharma Research, Inc.20150—
+2K210421Diafil & Diafil CapsuleDiaDent Group International20210—