DeviceClearance

Product code EIE— Dental

DREAM DAM

Classification name
Dam, Rubber
Device class
Class 1
Regulation
21 CFR 872.6300
Advisory panel
Dental
Total cleared
33
First cleared
Most recent

Market context for product code EIE

FDA has cleared 33 devices under product code EIE between 1978 and 2019, filed by 26 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

last 15 years

Top applicants under product code EIE

Recent clearances under product code EIE

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