# K111216: Osseotite 2 Dental Implants

- Pathway: 510(k) (Special)
- Applicant: Biomet 3i, Inc.
- Decided: Nov 18, 2011 after 200 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: 11 generations back to K925765 (1993). 67 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100724: Osseotite II Model Xifossxxx, Biomet 3i, Inc. (2011) Summary page 1.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 1.

## Most influential descendants
- K133049: 3I T3(R) External Hex Dental Implants (2014), 19 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 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 with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. OSSEOTITE® 2 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/K111216
Methodology: https://510kreport.com/methodology