FDA product code NSR: Prosthesis, Orthodontic
NSR is the FDA product code for prosthesis, orthodontic. It is a Not classified device, reviewed by the Dental panel. Devices under NSR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NSR devices.
Definition
Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Orthodontic |
| Device class | Not classified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for NSR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-07-22.
Frequently asked questions
What is FDA product code NSR?
NSR is the FDA product code for prosthesis, orthodontic. It is a Not classified device, reviewed by the Dental panel.
What device class is NSR?
Not classified. Typical premarket route: 510(k) exempt.
Have NSR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-07-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NSR
- Run a recall and safety report across every NSR manufacturer
- Watch product code NSR 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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