# FDA recall Z-0690-2019

> **Ultradent Products, Inc.** · Class II · device recall initiated 2018-07-12.

## 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

## Reason for recall

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

## 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

## Key facts

- **Recall number:** Z-0690-2019
- **Recalling firm:** Ultradent Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-12
- **Report date:** 2019-01-09
- **Termination date:** 2019-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0690-2019

## Citation

> AI Analytics. FDA recall Z-0690-2019. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0690-2019. Source: US FDA. Licensed CC0.

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