FDA product code NMW: Needle, Dental, Reprocessed
NMW is the FDA product code for needle, dental, reprocessed. It is a Class I device, regulated under 21 CFR 872.4730 and reviewed by the Dental panel. Devices under NMW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
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 | Needle, Dental, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 872.4730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NMW devices
openFDA lists no recalls for product code NMW.
Frequently asked questions
What is FDA product code NMW?
NMW is the FDA product code for needle, dental, reprocessed. It is a Class I device, regulated under 21 CFR 872.4730 and reviewed by the Dental panel.
What device class is NMW?
Class I, regulation 21 CFR 872.4730. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMW
- Run a recall and safety report across every NMW manufacturer
- Watch product code NMW 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.