DeviceClearance

Product code EKJ— Dental

DENTAL HAND INSTRUMENTS

Classification name
Burnisher, Operative
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
72
First cleared
Most recent

Market context for product code EKJ

FDA has cleared 72 devices under product code EKJ between 1982 and 1996, filed by 46 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 EKJ

Recent clearances under product code EKJ

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