Ultradent Products, Inc. Recalls

All product recalls associated with Ultradent Products, Inc..

Get alerts for this brand

Recall Summary

Total Recalls

8

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–8 of 8 recalls

Transcend Econo Kit (Ultradent) – Manufacturing Particulate Issue (2024)

Due to a manufacturing issue, red particulates present in the expressed composite.

FDAAug 2, 2024AZ, CA, CO +32 more• Ultradent Products, Inc.

Vit-l-escence Singles (Ultradent) – Manufacturing Particulate Issue (2024)

Due to a manufacturing issue, red particulates present in the expressed composite.

FDAAug 2, 2024AZ, CA, CO +32 more• Ultradent Products, Inc.

Ultradent Products, Inc.: Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Pea...

SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.

FDAJun 1, 2022Nationwide• Ultradent Products, Inc.

Ultradent Products, Inc.: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Produc...

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

FDAAug 31, 2020Nationwide• Ultradent Products, Inc.

Opalescence Treswhite Supreme Kit (Ultradent) – incorrect shelf life (2013)

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

Class IIILow

FDAMar 8, 2013AL, CA, GA +10 more• Ultradent Products, Inc.

Spearmint Xylishield Gum (Ultradent) – Lot Recall (2012)

Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.

Class IIModerate

FDAJun 18, 2012GA• Ultradent Products, Inc.

Xylishield Dental Kit (Ultradent) – Lot Recall (2012)

Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.

Class IIModerate

FDAJun 18, 2012GA• Ultradent Products, Inc.

Cinnamon Xylishield Gum (Ultradent) – Lot Recall (2012)

Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.

Class IIModerate

FDAJun 18, 2012GA• Ultradent Products, Inc.

Stay Informed

Ultradent Products, Inc. Recalls

Recall Summary

Transcend Econo Kit (Ultradent) – Manufacturing Particulate Issue (2024)

Vit-l-escence Singles (Ultradent) – Manufacturing Particulate Issue (2024)

Ultradent Products, Inc.: Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Pea...

Ultradent Products, Inc.: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Produc...

Opalescence Treswhite Supreme Kit (Ultradent) – incorrect shelf life (2013)

Spearmint Xylishield Gum (Ultradent) – Lot Recall (2012)

Xylishield Dental Kit (Ultradent) – Lot Recall (2012)

Cinnamon Xylishield Gum (Ultradent) – Lot Recall (2012)