# K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Dec 30, 2002 after 194 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: 3 generations back to K925765 (1993). 9 ancestors in all.
478 later devices descend from it; 13 cite it directly.
0 of 488 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). Our reading of the summary gave K014265, 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 NT Implant System”.
- 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) Summary page 1.
- K013570: Osseotite Dental Implants, Implant Innovations, Inc. (2001)
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 2.

## Most influential descendants
- K031475: Osseotite NT Certain Implants (2003), 330 descendants of its own
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants (2003), 320 descendants of its own
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own

## Indications for use
3i Dental Implant Systems are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient’s chewing function.

Source page: https://510kreport.com/device/K022009
Methodology: https://510kreport.com/methodology