DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor— 510(k) K192381

Name: FDA 510(k) clearance K192381
Creator: U.S. Food and Drug Administration
Published: 2020-02-18

Substantially Equivalent

Scientific Pharmaceuticals

FDA 510(k) clearance K192381 for DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor, Substantially Equivalent on 2020-02-18. Applicant: Scientific Pharmaceuticals. Device class: 2.

Clearance details

Applicant: Scientific Pharmaceuticals
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2019-08-30
Decision date: 2020-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, 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.