AHL GENERIC GLASS IONOMER LUTING CEMENT— 510(k) K023981

Name: FDA 510(k) clearance K023981
Creator: U.S. Food and Drug Administration
Published: 2003-01-31

Substantially Equivalent

Advanced Healthcare , Ltd.

FDA 510(k) clearance K023981 for AHL GENERIC GLASS IONOMER LUTING CEMENT, Substantially Equivalent on 2003-01-31. Applicant: Advanced Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Advanced Healthcare , Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2002-12-02
Decision date: 2003-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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