DeviceClearance

Product code ELL— Dental

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL

Classification name
Teeth, Porcelain
Device class
Class 2
Regulation
21 CFR 872.3920
Advisory panel
Dental
Total cleared
39
First cleared
Most recent

Market context for product code ELL

FDA has cleared 39 devices under product code ELL between 1977 and 2024, filed by 25 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 ELL

Recent clearances under product code ELL

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