FDA-Device2018-11-07Class II
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
3M Company - Health Care Business
Hazard
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Sold states
US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Affected count
73 units (200 pack)
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
Products
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2019Don't want to check this manually?
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