# K062636: Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Jun 1, 2007 after 269 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: 9 generations back to K925765 (1993). 62 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 91 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) Summary page 1.
- 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.
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K030614: 3I Dental 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) Summary page 1.
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.
- K062432: Nanotite Dental Implants, Implant Innovations, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K100724: Osseotite II Model Xifossxxx (2011), 27 descendants of its own
- K122300: T3 Dental Implant (2013), 22 descendants of its own
- K111216: Osseotite 2 Dental Implants (2011), 21 descendants of its own
- K133049: 3I T3(R) External Hex Dental Implants (2014), 19 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own

## Indications for use
BIOMET 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 utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Source page: https://510kreport.com/device/K062636
Methodology: https://510kreport.com/methodology