Recall Z-0368-2019— 3M Company - Health Care Business

Name: FDA recall Z-0368-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-06

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2018-07-06, terminated 2019-02-26. It names one FDA 510(k) clearance: K132109. Product: 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.. Reason: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2018-07-06
Terminated: 2019-02-26
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K132109 — ENAMELASTUltradent Products Inc. / Oratech, LLC·cleared 2013-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.