One-Fil LC— 510(k) K261728
Substantially EquivalentMediclus Co., Ltd.
FDA 510(k) clearance K261728 for One-Fil LC, Substantially Equivalent on 2026-07-21. Applicant: Mediclus Co., Ltd.. Device class: 2.
Summary
Mediclus's One-Fil LC is filed under EJK, calcium hydroxide cavity liners. The record doesn't expand "LC" or give the product's composition.
Class II, 21 CFR 872.3250. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Mediclus filed from Cheongju-si, South Korea. Review took 56 calendar days (May 26 to July 21, 2026).
Clearance details
- Applicant
- Mediclus Co., Ltd.
- Product code
- Product code EJK
- Device class
- Class 2
- Regulation
- 21 CFR 872.3250
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
Recent devices under product code EJK
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