DeviceClearance

Product code EJJ— Dental

AMALCAP PLUS

Classification name
Alloy, Amalgam
Device class
Class 2
Regulation
21 CFR 872.3070
Advisory panel
Dental
Total cleared
74
First cleared
Most recent

Market context for product code EJJ

FDA has cleared 74 devices under product code EJJ between 1976 and 2005, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code EJJ

Recent clearances under product code EJJ

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