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U.S. Department of Health and Human Services

Product Classification

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Device dental barriers and sleeves
Regulation Description Surgical drape and drape accessories.
Definition Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Physical State Clear polymer film
Technical Method Adhesively applied to patient contacting surfaces of reusable dental instruments/devices.
Target Area For devices to be used in dental surgery.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Dental
Product CodePEM
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 878.4370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible