FDA product code NRU: Chair, Dental, Without Operative Unit
NRU is the FDA product code for chair, dental, without operative unit. It is a Class I device, regulated under 21 CFR 872.6250 and reviewed by the Dental panel. Devices under NRU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for NRU devices.
Definition
A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Dental, Without Operative Unit |
| Device class | Class I |
| Regulation | 21 CFR 872.6250 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NRU devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-04.
Frequently asked questions
What is FDA product code NRU?
NRU is the FDA product code for chair, dental, without operative unit. It is a Class I device, regulated under 21 CFR 872.6250 and reviewed by the Dental panel.
What device class is NRU?
Class I, regulation 21 CFR 872.6250. Typical premarket route: 510(k) exempt.
Have NRU devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2011-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NRU
- Run a recall and safety report across every NRU manufacturer
- Watch product code NRU 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times