One-Fil Putty— 510(k) K243353

Substantially Equivalent

Mediclus Co., Ltd.

FDA 510(k) clearance K243353 for One-Fil Putty, Substantially Equivalent on 2025-03-14. Applicant: Mediclus Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mediclus Co., Ltd.
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2024-10-29
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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K253167 — Any-Paste2026-01-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.