# K251660: T3 Pro Implants– ZimVie Packaging System

- Pathway: 510(k) (Special)
- Applicant: Biomet 3i, LLC
- Decided: Jun 27, 2025 after 28 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: 13 generations back to K925765 (1993). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213672: T3 Pro Implants, Biomet 3i, LLC (2022) Summary page 5.

## 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/K251660
Methodology: https://510kreport.com/methodology