510(k) Report

Devices descending from K132953

14 later devices reach Tidisheild through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261956Dental Barriers and Sleeves (AB0006)ANI Co., Ltd.20260—
+1K160232Disposable Barrier Sleeves and CoversDentsply International, Inc.20163—
+1K151123Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc.20169—
+2K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation20200—
+2K191448Barrier SleevesIvoclar Vivadent, AG20191—
+2K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.20194—
+2K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation20190—
+2K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited20171—
+3K250735Dental Barrier and SleevesFomed Industries, Inc.20250—
+3K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.20251—
+3K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory20242—
+3K211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB20210—
+3K190949ScanX Barrier EnvelopesAir Techniques, Inc.20190—
+4K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE20260—