FDA product code NLD: Instrument, Diamond, Dental, Reprocessed
NLD is the FDA product code for instrument, diamond, dental, reprocessed. It is a Class I device, regulated under 21 CFR 872.4535 and reviewed by the Dental panel. Devices under NLD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
same as DZP except reprocessed. 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 | Instrument, Diamond, Dental, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 872.4535 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLD devices
openFDA lists no recalls for product code NLD.
Frequently asked questions
What is FDA product code NLD?
NLD is the FDA product code for instrument, diamond, dental, reprocessed. It is a Class I device, regulated under 21 CFR 872.4535 and reviewed by the Dental panel.
What device class is NLD?
Class I, regulation 21 CFR 872.4535. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLD
- Run a recall and safety report across every NLD manufacturer
- Watch product code NLD 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.