Class 2 Device Recall Enamelast Cool Mint/OT Varnish 5 NaF Mint

• Date Initiated by Firm: July 12, 2018
• Create Date: January 03, 2019
• Recall Status: Terminated on February 19, 2019
• Recall Number: Z-0690-2019
• Recall Event ID: 81407
• 510(K)Number: K132109
• Product Classification: Varnish, cavity - Product Code LBH
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Ultradent Products, Inc.; 505 W 10200 S; South Jordan UT 84095-3800
• For Additional Information Contact: Corey Jaseph; 801-553-4420
• Manufacturer Reason for Recall: Dental varnish has the possibility of having an unpleasant and off flavor.
• FDA Determined 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: adam.black@ultradent.com
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LBH