Z-0690-2019Class II

Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium...

Name: Z-0690-2019 Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium...
Creator: Ultradent Products, Inc.
Published: 2018-07-12
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2018-07-12 / Terminated

FDA source

Ultradent Products, Inc. began a recall of Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352... on 2018-07-12. FDA classified it as Class II and gives the reason as "Dental varnish has the possibility of having an unpleasant and off flavor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0690-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Posted: 2019-01-03
Terminated: 2019-02-19
Recalling firm: Ultradent Products Inc.
Product: Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Product code: LBH Varnish, Cavity
Reason for recall: Dental varnish has the possibility of having an unpleasant and off flavor.
FDA root cause: Mixed-up of materials/components
Action: On July 3, 2018, the firm sent an URGENT PRODUCT CORRECTION Notification to customers via UPS informing them that the Cool Mint flavor Fluoride Varnish has the possibility of having an unpleasant and off flavor, atypical of the refreshing cool mint flavor that they are used to. If the customer has any questions regarding this correction or directions to the actions required, please contact Adam Black at 801-553-4425 or Karen Kakunes at 801-553-4366. Customer are instructed to take the following actions for tracing and documentation purposes: -Discard remaining inventory of Enamelast Cool Mint flavor product from the identified part and lot number above. -Respond to this letter by completing the "RETURN RESPONSE form and returning it to Ultradent Products, Inc., to the attention of Adam Black with the contact information provided. Please fill out and return via fax or email to Adam Black at Ultradent Products Inc. Fax: 801-553-4609 or E-mail: [email protected]
Quantity in commerce: 1654 units
Distribution: Worldwide Distribution - US Nationwide: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY OUS: Germany, Italy, Malaysia, and Poland
Product codes and lots: Part No. Description Lot No. 4352 Enamelast Unit Dose 200pk Cool Mint BFS7K 4353 Enamelast Unit Dose 50pk Cool Mint BFPX5 4368 Enamelast Unit Dose 200pk Variety Pack BFRJZ, BFTQG 4575 OEM MMM Varnish Mint 200pk BFLSB Confidential private label customer 3380 OEM Contract CG Varnish Kit Mint 12pk BFH9D Confidential private label customer

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0690-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0690-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-09	2019-01-03

Product code LBH

K132109Class IIEnamelastUltradent Products Inc. / Oratech, LLC / cleared 2013-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)