510(k) Report

Devices descending from K101485

4 later devices reach All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch-… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221450Phosphoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd.20220—
+1K140846Eds Combo-RinseEssential Dental Systems, Inc.20140—
+1K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+1K113401Ortho-1(Not Finalized)Bisco, Inc.20120—