FDA product code NME: Bur, Diamond Coated, Reprocessed
NME is the FDA product code for bur, diamond coated, reprocessed. It is a Class I device, regulated under 21 CFR 872.3240 and reviewed by the Dental panel. Devices under NME reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NME devices.
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 | Bur, Diamond Coated, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 872.3240 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NME devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-28.
Frequently asked questions
What is FDA product code NME?
NME is the FDA product code for bur, diamond coated, reprocessed. It is a Class I device, regulated under 21 CFR 872.3240 and reviewed by the Dental panel.
What device class is NME?
Class I, regulation 21 CFR 872.3240. Typical premarket route: 510(k).
Have NME devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code NME
- Run a recall and safety report across every NME manufacturer
- Watch product code NME 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.