Fiberfill Sgp

• • Terminated Z-0488-2010 FDA Unclassified (pre-2012) ·initiated 27 Oct 2009

  The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart

510(k) Number

K023819 ↗

FDA Product Code

EKM

Device Class

Class I

Regulation

21 CFR Part 872.3850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Trionomer

  Class II

  FDA 510(k) K022150 Active Cleared 21 Aug 2002

• Fiberfill AGP

  Class II

  FDA 510(k) K023818 Active Cleared 3 Apr 2003

• SE Epiphany Root Canal Sealant, Model N59SE

  Class II

  FDA 510(k) K060889 Active Cleared 27 Oct 2006

• Avante Led Curing Unit, Model N44

  Class II

  FDA 510(k) K052349 Active Cleared 21 Oct 2005

• Generation 8 Se Adhesive

  Class II

  FDA 510(k) K072480 Active Cleared 21 Nov 2007

• Rm Bond, Model J032

  Class II

  FDA 510(k) K072830 Active Cleared 4 Dec 2007

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