K5 Cart, K5 Mount, K5 Swing— 510(k) K251491

Name: FDA 510(k) clearance K251491
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Substantially Equivalent

Osstem Implant Company., Ltd. Chair Business

FDA 510(k) clearance K251491 for K5 Cart, K5 Mount, K5 Swing, Substantially Equivalent on 2025-07-17. Applicant: Osstem Implant Company., Ltd. Chair Business. Device class: 1.

Clearance details

Applicant: Osstem Implant Company., Ltd. Chair Business
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2025-05-14
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Ansan-Si, KR

Download summary PDF View on FDA.gov ↗

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