GILB-2, GLASS IONOMER PROTECTIVE COATING— 510(k) K073395

Name: FDA 510(k) clearance K073395
Creator: U.S. Food and Drug Administration
Published: 2008-01-17

Substantially Equivalent

3M Espe Dental Products

FDA 510(k) clearance K073395 for GILB-2, GLASS IONOMER PROTECTIVE COATING, Substantially Equivalent on 2008-01-17. Applicant: 3M Espe Dental Products. Device class: 2.

Clearance details

Applicant: 3M Espe Dental Products
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2007-12-03
Decision date: 2008-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.