3I Locater Abutment System

• 9 recalls, same reason

  • Terminated Z-2487-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2427-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2431-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2430-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2428-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2433-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2432-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2429-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2480-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

• • Terminated Z-0810-2010 FDA Unclassified (pre-2012) ·initiated 23 Nov 2009

  Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.

• • Terminated Z-1363-2008 FDA Unclassified (pre-2012) ·initiated 7 Feb 2008

  Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa

510(k) Number

K012911 ↗

FDA Product Code

DZE

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

See all devices from Implant Innovations, Inc. →

• Is the 3I Locater Abutment System intended for single-tooth or multi-tooth implant restorations, and how does it ensure stability in the oral environment?

  The 3I Locater Abutment System is designed to connect prosthetic components to dental implants for both single-tooth and multi-tooth implant-supported restorations. Its stability comes from a precise, root-form interface that ensures mechanical retention and alignment, which is critical for long-term success in the oral environment. This design helps maintain the integrity of the restoration while accommodating natural occlusal forces.

• How is the 3I Locater Abutment System supplied, and what sterilization process is required before use?

  The 3I Locater Abutment System is supplied as a reusable, non-sterile component. Since it is intended for clinical use, it must be sterilized prior to implantation to ensure patient safety. The system follows standard dental implant protocols for sterilization, which typically include methods like autoclaving or chemical sterilization, depending on the clinical setting’s procedures.

• What regulatory pathway was followed for the FDA clearance of the 3I Locater Abutment System, and what does this mean for its use in dental practices?

  The 3I Locater Abutment System received FDA clearance through a 510(k) submission (K012911), classified under FDA Class II with Special Controls for dental implants (product code DZE). This means the device was determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. Clinicians can rely on this clearance as evidence that the system adheres to regulatory standards for dental implant abutments.

• Can the 3I Locater Abutment System be used with any dental implant system, or is it specific to certain brands?

  The 3I Locater Abutment System is designed to provide a standardized interface for connecting prosthetic components to dental implants, but its compatibility depends on the specific implant platform and abutment connection type used in the patient’s case. While the system itself is not branded for a single manufacturer, it must align with the mechanical specifications of the implant system being utilized. Clinicians should verify compatibility with their chosen implant brand before use.