Spirit Mb

• • Terminated Z-1330-2014 FDA Class II ·initiated 25 Mar 2014

  Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.

• 2 recalls, same reason

  • Terminated Z-0200-2012 FDA Unclassified (pre-2012) ·initiated 18 May 2011
  • Terminated Z-0201-2012 FDA Unclassified (pre-2012) ·initiated 18 May 2011

  Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.

510(k) Number

K943245 ↗

FDA Product Code

DYW

Device Class

Class II

Regulation

21 CFR Part 872.5470

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

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  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →