FDA product code NME

Bur, Diamond Coated, Reprocessed

Dental·Class 1·21 CFR 872.3240
US regulatory classifications
US Product Code (FDA)
NME
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 872.3240
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Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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About this record

Bur, Diamond Coated, Reprocessed is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.