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