Device product
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.
Z-1822-2012
Product summary
- Event
- Event 62120
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172 kits (4 syringes per kit)
- Official record key
device-enforcement:Z-1822-2012
Official wording
Reason: Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
Code information: Lot number: B6Z4K.
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Labeling or packaging
mislabeled