One-Fil LC— 510(k) K261728

Substantially Equivalent

Mediclus Co., Ltd.

FDA 510(k) clearance K261728 for One-Fil LC, Substantially Equivalent on 2026-07-21. Applicant: Mediclus Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mediclus Co., Ltd.
Product code: Code EJK
Device class: Class 2
Regulation: 21 CFR 872.3250
Advisory panel: Dental
Date received: 2026-05-26
Decision date: 2026-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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