Gluma Comfort Bond + Desensitizer

• 2 recalls, same reason

  • Terminated Z-0035-2008 FDA Unclassified (pre-2012) ·initiated 9 Jul 2007
  • Terminated Z-0036-2008 FDA Unclassified (pre-2012) ·initiated 9 Jul 2007

  The material may solidify in the bottle, and thus be rendered unusable.

510(k) Number

K992292 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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