DURAGARD SODIUM FLUORIDE VARNISH— 510(k) K002581

Name: FDA 510(k) clearance K002581
Creator: U.S. Food and Drug Administration
Published: 2000-10-20

Substantially Equivalent

Sultan Dental Products, Ltd.

FDA 510(k) clearance K002581 for DURAGARD SODIUM FLUORIDE VARNISH, Substantially Equivalent on 2000-10-20. Applicant: Sultan Dental Products, Ltd.. Device class: 2.

Clearance details

Applicant: Sultan Dental Products, Ltd.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2000-08-18
Decision date: 2000-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, NJ, 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.