Dual-Cure Radiopaque

• 5 recalls, same reason

  • Terminated Z-0153-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-0154-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-0155-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-0157-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-0156-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011

  Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.

510(k) Number

K874189 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• C-17

  Class II

  FDA 510(k) K841268 Active Cleared 22 May 1984

• Number 21 R/R System

  Class II

  FDA 510(k) K841457 Active Cleared 22 May 1984

• #24L System

  Class II

  FDA 510(k) K873878 Active Cleared 27 Oct 1987

• Number 20 R/L System

  Class II

  FDA 510(k) K841458 Active Cleared 22 May 1984

• Pentra-Fil II

  Class II

  FDA 510(k) K840727 Active Cleared 13 Apr 1984

• C-18

  Class II

  FDA 510(k) K841267 Active Cleared 30 Apr 1984

See all devices from Pentron Corp. →