NQS — Bracket, Metal, Orthodontic, Reprocessed Class I
FDA product code NQS covers "Bracket, Metal, Orthodontic, Reprocessed", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- NQS
- Device Class
- Class I
- Regulation Number
- 872.5410
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
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).