# K063286: Osseotite; Osseotite NT; XP; TG Osseotite

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 24, 2007 after 175 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K925765 (1993). 62 ancestors in all.
211 later devices descend from it; 10 cite it directly.
0 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K972444: 3I Innovative Implants and Cover Screws, Implant Innovations, Inc. (1997) Summary page 1.
- K980549: Osseotite Dental Implant System, Implant Innovations, Inc. (1998) Summary page 1.
- K983347: Osseotite Dental Implants, Implant Innovations, Inc. (1999) Summary page 1.
- K992334: Endosseous Implants and Abutments- Tin Coating, Implant Innovations, Inc. (1999) Summary page 1.
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002) Summary page 1.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K033430: 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615, Implant Innovations, Inc. (2003) Summary page 1.
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K030164: Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black Color, Latex Examination Gloves with Protein, Yty Industry (Manjung) Sdn Bhd (2003). Our reading of the summary gave K030164, FDA’s number for Non-Sterile, Powder-Free, Polymer Coated, Natural and/or… (Yty Industry (Manjung) Sdn Bhd). Its FDA name has none of the distinctive words the summary uses for the device it names, “3i OSSEOTITE Dental Implants”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K150295: LOCATOR RTx (2015), 42 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## Recalls of this device
- Mar 8, 2017 · Class II · Z-1701-2017: 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
- Nov 25, 2015 · Class II · Z-2458-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2469-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2457-2016: Pouches may not have been sealed during packing.
- Aug 3, 2007 · Not classified · Z-1221-2007: 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.

## Indications for use
3i dental implants are intended for surgical placement in the upper or lowerjaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, > 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K063286
Methodology: https://510kreport.com/methodology