Class IIITerminated in FDA datasetRecall initiated Mar 8, 2013

Opalescence Treswhite Supreme Peach Patient Kit

Recalling firm: Ultradent Products, Inc.

Why it was recalled

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Jul 9, 2013.

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ProductOpalescence Treswhite Supreme Peach Patient Kit

FDA code information

Lot B6LZS, Part number 5705

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Full FDA record and distribution details

Original product description

Opalescence Treswhite Supreme Peach Patient Kit

Original FDA recall reason

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

Recall details

Recall number
F-1271-2013
Event ID
64534
FDA status
Terminated
Initiated
Mar 8, 2013
Reported
Apr 3, 2013
Classified
Mar 26, 2013
Terminated
Jul 9, 2013
Quantity
104 units
Location
South Jordan, UT, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was distributed

USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain

FDA source record · F-1271-2013

Data updated September 16, 2026. View official FDA data ↗

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