EBC
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260819 | 2026-05-01 | Mediclus Co., Ltd. | Any-Com Seal | |
| K243254 | 2025-08-08 | Parkell, Inc. | Parkell Pit and Fissure Sealant |
Official FDA classification page: EBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).