S&C-Self Etch Pr-Bond

• 2 recalls, same reason

  • Terminated Z-2128-2014 FDA Class II ·initiated 16 Jul 2014
  • Terminated Z-2129-2014 FDA Class II ·initiated 16 Jul 2014

  Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

510(k) Number

K042614 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• S & C -Bracket Adhesives

  Class II

  FDA 510(k) K031420 Active Cleared 20 Aug 2003

• Root Canal Xr

  Class II

  FDA 510(k) K083062 Active Cleared 12 Mar 2009

• Resin Cem

  Class II

  FDA 510(k) K011431 Active Cleared 11 Jun 2001

• Lc Flowfill

  Class II

  FDA 510(k) K990108 Active Cleared 9 Mar 1999

• Classic Cem

  Class II

  FDA 510(k) K011064 Active Cleared 17 May 2001

• Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect

  Class II

  FDA 510(k) K082115 Active Cleared 15 Jan 2009

See all devices from S & C Polymer GmbH →