Z-0454-2012

Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended...

Name: Z-0454-2012 Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended...
Creator: Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Published: 2011-03-17
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2011-03-17 / Terminated

FDA source

Kerr/pentron Dba Kerr Corporation And Pentron Clinical began a recall of Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such... on 2011-03-17. The reason FDA records is "The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0454-2012
Status: Terminated
Initiated: 2011-03-17
Posted: 2012-01-11
Terminated: 2014-01-22
Recalling firm: Sybron Dental Specialties, Inc.
Product: Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.
Product code: EMA Cement, Dental
Reason for recall: The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.
FDA root cause: Other
Action: The firm, Pentron Clinical, sent an " URGENT: MEDICAL DEVICE RECALL" letters dated April 4, 2011 and April 20, 2011 via USPS 1st class mail to its customers. The letter describes the product, problem and actions to be taken. The letter instructed customers to review the table with affected product lots and determine if the affected products was in their inventory; return the affected product for a replacement at no charge; contact Pentron Clinical Customer Service at (800) 551-0283; 1-800-243-3969 ext. 677 or email: [email protected] directly to handle the arrangements of a quick return and replacement; and complete and fax back the enclosed Recall Return Form at 1-877-677-8844. The letter also request the customer to identify and recover the affected product lots that may have been shipped to thier customers. If you have any questions, contact Pentron Clinical Customer Service at (800) 551-0283.
Quantity in commerce: 157
Distribution: Worldwide distribution: USA (nationwide) including states of: PA, IL, NV, WA, OH, TN, WI, NY, NJ, CT, IN FL, MI, OK, NE, HI, VA, CA, and TX; and countries of : Canada, Egypt, Isreal, Netherlands, Sweden and UK.
Product codes and lots: Product under the brand name Cement-It: Part No. N33, N33A; Syringe Lot No. 183058; Package Lot No. 186272, 186665, 186676. Product under the brand name Natural Elegance (Private Label of Cement-It): Part No. SHN9004110; Syringe Lot No. 183058; Package Lot 182990, 186133, 188996.

Product code EMA

K000173Class IICement It! Universal C&bJeneric/Pentron, Inc. / cleared 2000-02-29

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)