3d19beab-7f36-4f2e-9a15-e6bfaf02cbffUpdatePublished52024-06-142016-10-052021-05-31Not in Commercial DistributionD024772153PrimaryHIBCCD0247721533Unit of UseHIBCCVELLAmini 5% Sodium Fluoride Varnish Caramel Box 100772153772153090735093Preventech100VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 100 0.5mL unit dose packagesfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse704-849-2416customerservice@preventech.comK14035000064794Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.falseActiveLBHVarnish, Cavityfalsefalse