EBC

Sealant, Pit And Fissure, And Conditioner

Product code
EBC
Device name
Sealant, Pit And Fissure, And Conditioner
Device class
Class 2
21 CFR
21 CFR 872.3765
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
131 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-01.

NumberDecision dateApplicantDevice nameSummary
K2608192026-05-01Mediclus Co., Ltd.Any-Com SealPDF
K2432542025-08-08Parkell, Inc.Parkell Pit and Fissure SealantPDF

2 summaries are archived here for direct download.

Official FDA classification page: EBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).