Cement-It All Purpose, Model N97

• • Terminated Z-0186-2012 FDA Unclassified (pre-2012) ·initiated 8 Jul 2011

  Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.

• • Terminated Z-1100-2012 FDA Unclassified (pre-2012) ·initiated 2 Dec 2010

  The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.

510(k) Number

K060698 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Fiberfill Sgp

  Class I

  FDA 510(k) K023819 Active Cleared 26 Mar 2003

• 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

See all devices from Pentron Clinical Technologies →