FDA product code NSM: Restoration, Resin
NSM is the FDA product code for restoration, resin. It is a Not classified device, reviewed by the Dental panel. Devices under NSM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
Classification
| Field | Value |
|---|---|
| Device name | Restoration, Resin |
| Device class | Not classified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for NSM devices
openFDA lists no recalls for product code NSM.
Frequently asked questions
What is FDA product code NSM?
NSM is the FDA product code for restoration, resin. It is a Not classified device, reviewed by the Dental panel.
What device class is NSM?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NSM
- Run a recall and safety report across every NSM manufacturer
- Watch product code NSM 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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