FDA product code NRD: Unit, Operative Dental, Accessories
NRD is the FDA product code for unit, operative dental, accessories. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under NRD, from 2 different applicants. The average 510(k) review took 68 days (median 68).
Definition
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Operative Dental, Accessories |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NRD clearance
Top NRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Takara Belmont USA, Inc. | 1 | 2007-12-20 |
| Air Techniques, Inc. | 1 | 2004-08-31 |
Most recent NRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072273 | Takara Belmont USA, Inc. | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | 2007-12-20 | 127 |
| K042266 | Air Techniques, Inc. | ACCLAIM | 2004-08-31 | 8 |
Recalls for NRD devices
openFDA lists no recalls for product code NRD.
Frequently asked questions
What is FDA product code NRD?
NRD is the FDA product code for unit, operative dental, accessories. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is NRD?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NRD?
Across 2 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most NRD clearances?
Takara Belmont USA, Inc. (1); Air Techniques, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRD
- Run a recall and safety report across every NRD manufacturer
- Watch product code NRD 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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