DeviceClearance

Product code EJR— Dental

PROPHY PASTE

Classification name
Agent, Polishing, Abrasive, Oral Cavity
Device class
Class 1
Regulation
21 CFR 872.6030
Advisory panel
Dental
Total cleared
77
First cleared
Most recent

Market context for product code EJR

FDA has cleared 77 devices under product code EJR between 1976 and 2017, filed by 54 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 EJR

Recent clearances under product code EJR

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