Product code EHM— Dental

PROFLEX FLEXIBLE SCALER

Classification name
Strip, Polishing Agent
Device class
Class 1
Regulation
21 CFR 872.6010
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

Market context for product code EHM

FDA has cleared 2 devices under product code EHM between 1979 and 1982, filed by 2 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 EHM

Recent clearances under product code EHM

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