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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 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 872.4535
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible