EJK
- Product code
- EJK
- Device name
- Liner, Cavity, Calcium Hydroxide
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3250
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 78 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261728 | 2026-07-21 | Mediclus Co., Ltd. | One-Fil LC | |
| K253248 | 2026-01-13 | Dmp Dental Industry S.A. | Bright Cavity Liner | — |
Official FDA classification page: EJK
Classification and pathway per current FDA publications. Data from openFDA (CC0).