# K241753: Immediate Molar Implants

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, LLC
- Decided: Oct 23, 2024 after 127 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: 14 generations back to K925765 (1993). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 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.
- K220978: TSX Implants, Biomet 3i, LLC (2022) Summary page 5.
- K150571: 3i T3 Short Implants, Biomet 3i (2015) Summary page 5.

## Indications for use
Immediate Molar 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar 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. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems: Abutment System Name Models Platform Diameters Abutments manufactured by Terrats Medical SL Titanium Abutments 4.1, 5.0 and 5.7mm Abutments manufactured by Zfx GmbH Titanium Abutments 4.1, 5.0 and 5.7mm

Source page: https://510kreport.com/device/K241753
Methodology: https://510kreport.com/methodology