DeviceClearance

Product code NRD— Dental

ACCLAIM

Classification name
Unit, Operative Dental, Accessories
Device class
Class 1
Regulation
21 CFR 872.6640
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NRD under 21 CFR 872.6640, via openFDA

Market context for product code NRD

FDA has cleared 2 devices under product code NRD between 2004 and 2007, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code NRD

Recent clearances under product code NRD

Data sourced from openFDA. This site is unofficial and independent of the FDA.