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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 Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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