BUTLER GUM PROPHY PASTE WITH NOVAMIN— 510(k) K024343

Name: FDA 510(k) clearance K024343
Creator: U.S. Food and Drug Administration
Published: 2003-07-11

Substantially Equivalent

Usbiomaterials Corp.

FDA 510(k) clearance K024343 for BUTLER GUM PROPHY PASTE WITH NOVAMIN, Substantially Equivalent on 2003-07-11. Applicant: Usbiomaterials Corp.. Device class: 1.

Clearance details

Applicant: Usbiomaterials Corp.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2002-12-27
Decision date: 2003-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

Download summary PDF View on FDA.gov ↗

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