K5— 510(k) K233805

Substantially Equivalent

Osstem Implant Co., Ltd. Chair Business

FDA 510(k) clearance K233805 for K5, Substantially Equivalent on 2024-09-03. Applicant: Osstem Implant Co., Ltd. Chair Business. Device class: 1.

Clearance details

Applicant: Osstem Implant Co., Ltd. Chair Business
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2023-11-29
Decision date: 2024-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
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.