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U.S. Department of Health and Human Services

Product Classification

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Device resin, denture, relining, repairing, rebasing
Regulation Description Denture relining, repairing, or rebasing resin.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEBI
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 872.3760
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons