Device type
Dental Barriers And Sleeves
Product code PEM · Class II · 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.
Recent 510(k)s
Sep 17, 2026
K262073
Hygienic Protective Bite Cover (2207-010-50)
Dürr Dental SE
- PEM
- Class II
Sep 8, 2026
K261956
Dental Barriers and Sleeves (AB0006)
ANI Co., Ltd.
- PEM
- Class II
Recent recalls
No recalls in the archive for PEM.