# K122300: T3 Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i
- Decided: Jan 30, 2013 after 183 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 3 (0 Class I)
- 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.
22 later devices descend from it; 2 cite it directly.
0 of 90 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.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 2.
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) 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
- K213672: T3 Pro Implants (2022), 2 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-1409-2015: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
- May 10, 2013 · Class II · Z-1960-2013: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the denta
- May 10, 2013 · Class II · Z-1961-2013: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the denta

## Indications for use
BIOMET 3/ 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.

Source page: https://510kreport.com/device/K122300
Methodology: https://510kreport.com/methodology