DeviceClearance

Product code EKN— Dental

ABSORBENT ENDODONTIC POINT

Classification name
Point, Paper, Endodontic
Device class
Class 1
Regulation
21 CFR 872.3830
Advisory panel
Dental
Total cleared
7
First cleared
Most recent

Market context for product code EKN

FDA has cleared 7 devices under product code EKN between 1976 and 1985, filed by 6 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 EKN

Recent clearances under product code EKN

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