# K213672: T3 Pro Implants

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, LLC
- Decided: Mar 28, 2022 after 126 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: 12 generations back to K925765 (1993). 68 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122300: T3 Dental Implant, Biomet 3i (2013) Summary page 4.

## Most influential descendants
- K251660: T3 Pro Implants– ZimVie Packaging System (2025), 0 descendants of its own
- K241753: Immediate Molar Implants (2024), 0 descendants of its own

## Indications for use
The T3 Pro 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro 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/K213672
Methodology: https://510kreport.com/methodology