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U.S. Department of Health and Human Services

Product Classification

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Device bur, diamond coated, reprocessed
Regulation Description Dental bur.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNME
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3240
Device Class 1
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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