Preformance Temporary Cylinder

• 2 recalls, same reason

  • Terminated Z-2493-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2415-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

• • Terminated Z-0128-2008 FDA Unclassified (pre-2012) ·initiated 8 Oct 2007

  Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.

510(k) Number

K060291 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 3I Dental Implant Accessories

  Class II

  FDA 510(k) K022113 Active Cleared 19 Sep 2002

• Modification to Osseotite Nt Certain Implants

  Class II

  FDA 510(k) K041402 Active Cleared 16 Jun 2004

• 3I Calcium Sulfate Bone Cement

  Class II

  FDA 510(k) K012047 Active Cleared 19 Sep 2001

• Provide Temporary Cylinder

  Class II

  FDA 510(k) K061177 Active Cleared 16 May 2006

• 3I Implants; Osseotite Dental Implants; Osseotite Nt Dental Implants

  Class II

  FDA 510(k) K022009 Active Cleared 30 Dec 2002

• TIL313 Abutment and Retaining Screw Systems

  Class II

  FDA 510(k) K962465 Active Cleared 20 Sep 1996

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