Z-0186-2012

Breeze Self-Adhesive Resin Cement, Part Number: N97A

Name: Z-0186-2012 Breeze Self-Adhesive Resin Cement, Part Number: N97A
Creator: Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Published: 2011-07-08
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2011-07-08 / Terminated

FDA source

Kerr/pentron Dba Kerr Corporation And Pentron Clinical began a recall of Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased... on 2011-07-08. The reason FDA records is "Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0186-2012
Status: Terminated
Initiated: 2011-07-08
Posted: 2011-11-14
Terminated: 2013-06-28
Recalling firm: Sybron Dental Specialties, Inc.
Product: Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Product code: EMA Cement, Dental
Reason for recall: Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
FDA root cause: Pending
Action: Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in commerce: 336 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
Product codes and lots: Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478

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)