Alginate Impression Material

• • Terminated Z-0128-06 FDA Unclassified (pre-2012) ·initiated 21 Sep 2005 ·on shared 510(k) K003426

  At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K003426 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Zinc Phosphate Cement

  Class II

  FDA 510(k) K003427 Active Cleared 24 Jan 2001

• Tooth Shade Resin Material

  Class II

  FDA 510(k) K011453 Active Cleared 23 Jul 2001

• Cavity Varnish

  Class II

  FDA 510(k) K010255 Active Cleared 20 Apr 2001

• Enamel Bonding System

  Class II

  FDA 510(k) K020050 Active Cleared 14 Feb 2002

• Pit and Fissure Chemical Curing Sealant

  Class II

  FDA 510(k) K011822 Active Cleared 7 Aug 2001

• Polycarboxylate (Pca) Cement

  Class II

  FDA 510(k) K010240 Active Cleared 27 Mar 2001