Product code EKH— Dental

BEACH AMALGAM CARVER

Classification name
Carver, Dental Amalgam, Operative
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
3
First cleared
Most recent

Market context for product code EKH

FDA has cleared 3 devices under product code EKH between 1978 and 1982, filed by 3 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 EKH

Recent clearances under product code EKH

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