Dental Barriers And Sleeves

FDA product code PEM · Class II (moderate risk) · 21 CFR 878.4370 · General, Plastic Surgery

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

16510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K261956Dental Barriers and Sleeves (AB0006)PEM · Traditional ANI Co., Ltd.09/08/2026SE
K250735Dental Barrier and SleevesPEM · Traditional Fomed Industries, Inc.06/10/2025SE
K250606Dental Barrier and SleevesPEM · Traditional Yueying Medical Instruments (Langfang) Co., Ltd.05/29/2025SE
K242435Dental Barrier and SleevesPEM · Traditional Wellmed Dental Medical Supply Co., Ltd.10/18/2024SE
K233918Dental Barrier and SleevesPEM · Traditional Yongqing Huaguan Dental Instruments Factory05/09/2024SE
K220662Disposable Barrier SleevesPEM · Traditional Premium Plus (Dongguan) Limited05/11/2022SE
K211026Minitube Dentasleeve Protective Barrier SleevesPEM · Traditional Minitube AB08/03/2021SE
K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPEM · Traditional Plasdent Corporation12/23/2020SE
K191448Barrier SleevesPEM · Traditional Ivoclar Vivadent, AG10/08/2019SE
K190484BH Medical Dental Barrier Sleeves and Barrier FilmPEM · Traditional Bh Medical Products Co., Ltd.09/10/2019SE
K190949ScanX Barrier EnvelopesPEM · Traditional Air Techniques, Inc.07/26/2019SE
K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopePEM · Traditional Unipack Medical Corporation06/14/2019SE
K163447Premium Plus Disposable Barrier SleevePEM · Traditional Premium Plus International Limited06/20/2017SE
K160232Disposable Barrier Sleeves and CoversPEM · Traditional Dentsply International, Inc.06/07/2016SE
K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM · Traditional Pac-Dent International, Inc.03/03/2016SE
K132953TidisheildPEM · Traditional Tidi Products,Llc02/18/2014SE