FDA product code NQS: Bracket, Metal, Orthodontic, Reprocessed
NQS is the FDA product code for bracket, metal, orthodontic, reprocessed. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. Devices under NQS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Bracket, Metal, Orthodontic, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NQS devices
openFDA lists no recalls for product code NQS.
Frequently asked questions
What is FDA product code NQS?
NQS is the FDA product code for bracket, metal, orthodontic, reprocessed. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is NQS?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NQS
- Run a recall and safety report across every NQS manufacturer
- Watch product code NQS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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