Bronchovideoscope Olympus Xbf-D160HM

• • Terminated Z-0917-2010 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009 ·via K040940, on the same 510(k)

  Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K040940 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

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  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

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  Not classified

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  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →