510(k) K192381

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 by Scientific Pharmaceuticals — Product Code LBH

K192381 is an FDA 510(k) premarket notification submitted by Scientific Pharmaceuticals for the device "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". The FDA issued a decision of Substantially Equivalent on February 18, 2020. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Scientific Pharmaceuticals has at least 10 other 510(k) clearances on record.