DeviceClearance

Product code JEP— Dental

DOUBLE BOW TOOTH SEPARATOR

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

Market context for product code JEP

FDA has cleared 3 devices under product code JEP between 1983 and 2009, 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 JEP

Recent clearances under product code JEP

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