DeviceClearance

Product code ELW— Dental

ALGINATE IMPRESSION MATERIAL

Classification name
Material, Impression
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Total cleared
402
First cleared
Most recent

Market context for product code ELW

FDA has cleared 402 devices under product code ELW between 1976 and 2026, filed by 162 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 ELW

Recent clearances under product code ELW

1–100 of 402

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