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Dental Barriers And Sleeves

FDA product code PEM · 16 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4370
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-03-03 – 2026-09-17

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

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