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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81407

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ultradent Products, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0690-2019
Recall number
Z-0690-2019
Initiated
July 12, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ultradent Products, Inc.
Quantity
1654 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dental varnish has the possibility of having an unpleasant and off flavor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

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