Z-1822-2012Class II

Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch...

Name: Z-1822-2012 Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch...
Creator: Ultradent Products, Inc.
Published: 2012-05-24
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2012-05-24 / Terminated / root cause: labeling and UDI

FDA source

Ultradent Products, Inc. began a recall of Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within... on 2012-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1822-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Posted: 2012-06-18
Terminated: 2012-08-15
Recalling firm: Ultradent Products Inc.
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.
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.
Quantity in commerce: 172 kits (4 syringes per kit)
Distribution: Worldwide Distribution.
Product codes and lots: Lot number: B6Z4K.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18

Product code KLE

K063558Class IIPeak Se, Model 5135Ultradent Products, Inc. / cleared 2006-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)