DeviceClearance

Product code EFD— Dental

ACCU-MIX AMALGAMATOR

Classification name
Amalgamator, Dental, Ac-Powered
Device class
Class 1
Regulation
21 CFR 872.3100
Advisory panel
Dental
Total cleared
15
First cleared
Most recent

Market context for product code EFD

FDA has cleared 15 devices under product code EFD between 1977 and 1999, filed by 12 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 EFD

Recent clearances under product code EFD

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