DeviceClearance

Product code EKM— Dental

GUTTA PERCHA POINTS

Classification name
Gutta-Percha
Device class
Class 1
Regulation
21 CFR 872.3850
Advisory panel
Dental
Total cleared
23
First cleared
Most recent

Market context for product code EKM

FDA has cleared 23 devices under product code EKM between 1982 and 2008, filed by 15 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 EKM

Recent clearances under product code EKM

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