Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr/pentron Dba Kerr Corporation And Pentron Clinical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60359
  • Event Risk Class
    Class 2
  • Event Number
    Z-0454-2012
  • Event Initiated Date
    2011-03-17
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105131
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cement, dental - Product Code EMA
  • Reason
    The firm initiated a recall because the product sets faster than specified in the "directions for use" and in release specifications.
  • 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 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.

Device

Device Recall Dental cement under the brand name CementIt and Natural Elegance
  • Model / Serial
    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 Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Manufacturer

Kerr/pentron Dba Kerr Corporation And Pentron Clinical
  • Manufacturer Address
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical, 1717 W. Collins Ave, Orange CA 92867
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA