Optibond Solo Plus 4

• • Terminated Z-1521-06 FDA Unclassified (pre-2012) ·initiated 29 Aug 2006

  Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

510(k) Number

K014027 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ez Connect Resin

  Class II

  FDA 510(k) K000357 Active Cleared 28 Apr 2000

• EZ Connect

  Class II

  FDA 510(k) K000346 Active Cleared 14 Apr 2000

• Belleglaze

  Class II

  FDA 510(k) K992067 Active Cleared 27 Aug 1999

• Bioplant

  Class II

  FDA 510(k) K050984 Active Cleared 11 Aug 2005

• Belleglass Hp Opaque 2

  Class II

  FDA 510(k) K013375 Active Cleared 29 Oct 2001

• Optibond Solo Plus 3

  Class II

  FDA 510(k) K011908 Active Cleared 6 Sep 2001

See all devices from Kerr Dental Materials Center →