Cement It! Universal C&B

• • Terminated Z-0454-2012 FDA Unclassified (pre-2012) ·initiated 17 Mar 2011

  The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.

510(k) Number

K000173 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• KB58-Kf

  Class II

  FDA 510(k) K922958 Active Cleared 26 Feb 1993

• Prop. Conquest C&B Vlc Glaze/Sealant

  Class II

  FDA 510(k) K953381 Active Cleared 27 Sep 1995

• Crown and Bridge Dental Restorative Composite Syst

  Class II

  FDA 510(k) K894644 Active Cleared 20 Oct 1989

• Orosphere Hcdp

  Class II

  FDA 510(k) K890681 Active Cleared 2 May 1989

• Conquest Crystal

  Class II

  FDA 510(k) K932154 Active Cleared 15 Sep 1993

• Bond-It Dual Cure Activator

  Class II

  FDA 510(k) K953859 Active Cleared 7 Sep 1995

See all devices from Jeneric/Pentron, Inc. →