FDA product code NLC: Bracket, Plastic, Orthodontic, Reprocessed
NLC is the FDA product code for bracket, plastic, orthodontic, reprocessed. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. Devices under NLC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
same as DYW except it is being 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 | Bracket, Plastic, Orthodontic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLC devices
openFDA lists no recalls for product code NLC.
Frequently asked questions
What is FDA product code NLC?
NLC is the FDA product code for bracket, plastic, orthodontic, reprocessed. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is NLC?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLC
- Run a recall and safety report across every NLC manufacturer
- Watch product code NLC 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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