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Parker Quality & Compliance

PQC Reg Watch

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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.

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for PEM.