DeviceClearance

Product code NEA— Dental

ENVOYCEM, MODEL 1640

Classification name
Cement, Ear, Nose And Throat
Device class
Class 2
Regulation
21 CFR 872.3275
Advisory panel
Dental
Total cleared
6
First cleared
Most recent

Market context for product code NEA

FDA has cleared 6 devices under product code NEA between 2001 and 2014, filed by 6 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

Top applicants under product code NEA

Recent clearances under product code NEA

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