P2 Polyether

• 4 recalls, same reason

  • Terminated Z-0625-05 FDA Unclassified (pre-2012) ·initiated 1 Nov 2003
  • Terminated Z-0627-05 FDA Unclassified (pre-2012) ·initiated 1 Nov 2003
  • Terminated Z-0626-05 FDA Unclassified (pre-2012) ·initiated 1 Nov 2003
  • Terminated Z-0624-05 FDA Unclassified (pre-2012) ·initiated 1 Nov 2003

  Packaging defects could result in improper mixing ratios and unusable impressions.

510(k) Number

K030318 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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