Product code EMR— Dental

CIMPAT

Classification name
File, Periodontic
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

Market context for product code EMR

FDA has cleared 1 device under product code EMR, all in 1983, filed by 1 applicant company. 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.

Top applicants under product code EMR

Recent clearances under product code EMR

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