510(k) Report

Devices descending from K190484

4 later devices reach BH Medical Dental Barrier Sleeves and Barrier Film through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250735Dental Barrier and SleevesFomed Industries, Inc.20250—
+1K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.20251—
+1K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory20242—
+2K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE20260—