DeviceClearance

Product code ELR— Dental

AD POST

Classification name
Post, Root Canal
Device class
Class 1
Regulation
21 CFR 872.3810
Advisory panel
Dental
Total cleared
35
First cleared
Most recent

Market context for product code ELR

FDA has cleared 35 devices under product code ELR between 1980 and 2006, filed by 27 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 ELR

Recent clearances under product code ELR

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