# K220978: TSX Implants

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, LLC
- Decided: Sep 14, 2022 after 163 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: 8 generations back to K894595 (1990). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072589: Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11, H13 and H16, Zimmer Dental, Inc. (2007) Summary page 4.

## Most influential descendants
- K241753: Immediate Molar Implants (2024), 0 descendants of its own

## Indications for use
The TSX Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability. The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

Source page: https://510kreport.com/device/K220978
Methodology: https://510kreport.com/methodology