METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER— 510(k) K081913

Name: FDA 510(k) clearance K081913
Creator: U.S. Food and Drug Administration
Published: 2008-09-05

Substantially Equivalent

Meta Biomed Co., Ltd.

FDA 510(k) clearance K081913 for METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER, Substantially Equivalent on 2008-09-05. Applicant: Meta Biomed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meta Biomed Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2008-07-03
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheung Ju City, Chung Buk, KR

Download summary PDF View on FDA.gov ↗

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