Z-1100-2012

Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain...

Name: Z-1100-2012 Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain...
Creator: Kerr Corporation
Published: 2010-12-02
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2010-12-02 / Terminated / root cause: manufacturing process

FDA source

Kerr Corporation began a recall of Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges... on 2010-12-02. The reason FDA records is "The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1100-2012
Status: Terminated
Initiated: 2010-12-02
Posted: 2012-02-24
Terminated: 2012-02-24
Recalling firm: Sybron Dental Specialties, Inc.
Product: Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
Product code: EMA Cement, Dental
Reason for recall: The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An "Urgent Medical Device Recall" letter was sent on 12/17/2010 via USPS 1st class mail to all their customers. The letter provides the customers with an explanation of the problem identified and the action to be taken. Customers were instructed to complete and fax back the enclosed recall return form. Customers with questions were instructed to call (800) 551-0283.
Quantity in commerce: 622 units total (12 units in US)
Distribution: Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
Product codes and lots: Lot # 200466

Product code EMA

K060698Class IICement-It All Purpose, Model N97Pentron Clinical Technologies / cleared 2006-05-10

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)