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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name varnish, cavity
510(k) Number K192381
Device Name 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
Scientific Pharmaceuticals
3221 Producer Way
Pomona,  CA  91768
Applicant Contact Thomas Kelly
Scientific Pharmaceuticals
3221 Producer Way
Pomona,  CA  91768
Correspondent Contact Thomas Kelly
Regulation Number872.3260
Classification Product Code
Date Received08/30/2019
Decision Date 02/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No