DeviceClearance

Product code EJK— Dental

IMPROVED DYCAL

Classification name
Liner, Cavity, Calcium Hydroxide
Device class
Class 2
Regulation
21 CFR 872.3250
Advisory panel
Dental
Total cleared
78
First cleared
Most recent

Market context for product code EJK

FDA has cleared 78 devices under product code EJK between 1976 and 2026, filed by 50 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 EJK

Recent clearances under product code EJK

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