510(k) Report

Devices descending from K160232

3 later devices reach Disposable Barrier Sleeves and Covers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261956Dental Barriers and Sleeves (AB0006)ANI Co., Ltd.20260—
+1K191448Barrier SleevesIvoclar Vivadent, AG20191—
+2K211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB20210—