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U.S. Department of Health and Human Services

Class 2 Device Recall Dental cement under the brand name CementIt and Natural Elegance

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 Class 2 Device Recall Dental cement under the brand name CementIt and Natural Elegancesee related information
Date Initiated by FirmMarch 17, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on January 22, 2014
Recall NumberZ-0454-2012
Recall Event ID 60359
510(K)NumberK000173 
Product Classification Cement, dental - Product Code EMA
ProductDental 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.
Code Information 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.
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr/pentron Dba Kerr Corporation And Pentron Clinical
1717 W. Collins Ave
Orange CA 92867
For Additional Information Contact
714-516-7400
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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: aestridge@pentron.com 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 Commerce157
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = EMA
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