Recall Z-0454-2012 · EMA Cement, Dental

Kerr/pentron Dba Kerr Corporation And Pentron Clinical

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, me

Date	Jan 11, 2012 (initiated Mar 17, 2011)
Status	Terminated
Reason	The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.
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: aestridge@pentron.com directly to handle the arrangements of a quick return a
Quantity	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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K000173

CEMENT IT! UNIVERSAL C&B
Jeneric/Pentron, Inc., Feb 29, 2000