DeviceClearance

Product code EKR— Dental

B&L L-BETA, MODEL WL-B1

Classification name
Plugger, Root Canal, Endodontic
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
6
First cleared
Most recent

Market context for product code EKR

FDA has cleared 6 devices under product code EKR between 1979 and 2006, 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 EKR

Recent clearances under product code EKR

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