FDA product code PEM

Dental Barriers And Sleeves

General, Plastic Surgery·Class 2·21 CFR 878.4370
US regulatory classifications
US Product Code (FDA)
PEM
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4370
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

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

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About this record

Dental Barriers And Sleeves is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.