NRD — Unit, Operative Dental, Accessories Class I
FDA product code NRD covers "Unit, Operative Dental, Accessories", a Class I medical device regulated under 21 CFR 872.6640. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRD
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- 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.