Bracket, Metal, Orthodontic, Reprocessed
- US Product Code (FDA)
- NQSView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 872.5410View CFR Regulation →
- Medical specialty
- Dental
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. 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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Bracket, Metal, Orthodontic, 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.
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