CLASS II Device recall · Reported 9 Jan 2019 · FDA Enforcement Report

Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast recalled

Ultradent Products is recalling Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose Cool Mint: Enamelast, distributed nationwide in the US. The recall was initiated on 12 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled1654 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0690-2019
FDA event ID: 81407
Recalling firm: Ultradent Products, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2018
FDA classified: 3 Jan 2019
Reported: 9 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Jul 2018	Recall initiated by company
3 Jan 2019	Classified by FDA	+175 days
9 Jan 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Dental varnish has the possibility of having an unpleasant and off flavor.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Dental varnish has the possibility of having an unpleasant and off flavor.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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