# K051461: 3I Osseotite Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 15, 2005 after 104 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K925765 (1993). 60 ancestors in all.
312 later devices descend from it; 7 cite it directly.
0 of 373 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002) Summary page 1.
- K972444: 3I Innovative Implants and Cover Screws, Implant Innovations, Inc. (1997) Summary page 1.
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K980549: Osseotite Dental Implant System, Implant Innovations, Inc. (1998) Summary page 1.
- K983347: Osseotite Dental Implants, Implant Innovations, Inc. (1999). Our reading of the summary gave K953347, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OSSEOTITE Dental Implants”.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants, Implant Innovations, Inc. (1996) Summary page 1.
- K031475: Osseotite NT Certain Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K030614: 3I Dental Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K041402: Modification to Osseotite NT Certain Implants, Implant Innovations, Inc. (2004) Summary page 1.
- K051189: Prevail Dental Implants, Implant Innovations, Inc. (2005). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own
- K063341: 3I Osseotite Certain Dental Implants (2007), 209 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K062432: Nanotite Dental Implants (2007), 59 descendants of its own

## Indications for use
3i dental implants are intended for surgical placement in the upper or lower jaw 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, > 10 mm in length, are placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K051461
Methodology: https://510kreport.com/methodology