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U.S. Department of Health and Human Services

Product Classification

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Device coating, filling material, resin
Regulation Description Coating material for resin fillings.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEBD
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 872.3310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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