METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING— 510(k) K032603

Name: FDA 510(k) clearance K032603
Creator: U.S. Food and Drug Administration
Published: 2003-10-07

Substantially Equivalent

Meta Biomed Co., Ltd.

FDA 510(k) clearance K032603 for METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING, Substantially Equivalent on 2003-10-07. Applicant: Meta Biomed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meta Biomed Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2003-08-25
Decision date: 2003-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmhurst, NY, US

Download summary PDF View on FDA.gov ↗

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