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Bur, Diamond Coated, Reprocessed

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.

Global Registration Data
Multi-Country Intelligence
Bur, Diamond Coated, Reprocessed
Dental Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NME

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Class 1

21 CFR 872.3240

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Dental

Device Characteristics

No

No

No

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).