TYPE I GLASS IONOMER CEMENT— 510(k) K942808

Name: FDA 510(k) clearance K942808
Creator: U.S. Food and Drug Administration
Published: 1994-11-03

Substantially Equivalent

Mion International Corp.

FDA 510(k) clearance K942808 for TYPE I GLASS IONOMER CEMENT, Substantially Equivalent on 1994-11-03. Applicant: Mion International Corp.. Device class: 2.

Clearance details

Applicant: Mion International Corp.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1994-06-15
Decision date: 1994-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winslow, IN, US

Download summary PDF View on FDA.gov ↗

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