DeviceClearance

Product code EMA— Dental

UNICEM

Classification name
Cement, Dental
Device class
Class 2
Regulation
21 CFR 872.3275
Advisory panel
Dental
Total cleared
508
First cleared
Most recent

Market context for product code EMA

FDA has cleared 508 devices under product code EMA between 1976 and 2026, filed by 175 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 EMA

Recent clearances under product code EMA

1–100 of 508

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