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U.S. Department of Health and Human Services

Product Classification

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Device instrument, diamond, dental, reprocessed
Regulation Description Dental diamond instrument.
Definition same as DZP except reprocessed
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNLD
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4535
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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