Bio-MEM Ti Reinforced Membrane— 510(k) K210797

Name: FDA 510(k) clearance K210797
Creator: U.S. Food and Drug Administration
Published: 2022-08-18

Substantially Equivalent

B&Medi Co., Ltd.

FDA 510(k) clearance K210797 for Bio-MEM Ti Reinforced Membrane, Substantially Equivalent on 2022-08-18. Applicant: B&Medi Co., Ltd.. Device class: 2.

Clearance details

Applicant: B&Medi Co., Ltd.
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2021-03-16
Decision date: 2022-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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