DeviceClearance

Product code EBC— Dental

ALPHA-DENT PIT AND FISSURE SEALANT

Classification name
Sealant, Pit And Fissure, And Conditioner
Device class
Class 2
Regulation
21 CFR 872.3765
Advisory panel
Dental
Total cleared
131
First cleared
Most recent

Market context for product code EBC

FDA has cleared 131 devices under product code EBC between 1976 and 2026, filed by 75 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 EBC

Recent clearances under product code EBC

1–100 of 131

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