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Ultradent Products, Inc.

FEI 1718912 · United States

Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports

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Import alerts
0
Import refusals (5 years)
0
Warning letters
0
Last FDA action
2013-03-08
13 years ago

FDA record

  1. 2013-03-08
    RecallRecall F-1271-2013 · Class 3 · Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.
    Opalescence Treswhite Supreme Peach Patient Kit
    Source: FDA Enforcement Reports
  2. 2012-06-18
    RecallRecall F-1708-2012 · Class 2 · 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.
    Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting …
    Source: FDA Enforcement Reports
  3. 2012-06-18
    RecallRecall F-1709-2012 · Class 2 · 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.
    Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
    Source: FDA Enforcement Reports
  4. 2012-06-18
    RecallRecall F-1710-2012 · Class 2 · 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.
    Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting…
    Source: FDA Enforcement Reports