Product code
NRD: Unit, operative dental, accessories
FDA product code · Class I · Dental
Key facts
| Product code | NRD |
|---|---|
| Device | Unit, operative dental, accessories |
| Device class | Class I |
| Regulation number | 872.6640 |
| Review panel | Dental |
| Medical specialty | Dental |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database