Ultradent Products, Inc.: Medical Device Recalls in 2012

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Ultradent Products, Inc. in 2012. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.