510(k) Report

Devices descending from K151123

9 later devices reach Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation20200—
+1K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.20194—
+1K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation20190—
+1K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited20171—
+2K250735Dental Barrier and SleevesFomed Industries, Inc.20250—
+2K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.20251—
+2K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory20242—
+2K190949ScanX Barrier EnvelopesAir Techniques, Inc.20190—
+3K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE20260—