OSSEOTITE - Osseotite Nt

• • Terminated Z-1701-2017 FDA Class II ·initiated 8 Mar 2017

  A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier

• 3 recalls, same reason

  • Terminated Z-2458-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2469-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2457-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

• • Terminated Z-1221-2007 FDA Unclassified (pre-2012) ·initiated 3 Aug 2007

  The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

510(k) Number

K063286 ↗

FDA Product Code

DZE

Models / Variants

Osseotite

Osseotite Nt

Xp

Tg Osseotite

Device Class

Class II

Regulation

21 CFR Part 872.3640

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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