# K242661: TRI-matrix® X-Force Implants

- Pathway: 510(k) (Traditional)
- Applicant: Tri Dental Implants Int. AG
- Decided: Jan 8, 2025 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: 16 generations back to K894595 (1990). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203660: TRI-matrix Implant Line, Tri Dental Implants Int. AG (2021) Summary page 5.

## Indications for use
TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.

Source page: https://510kreport.com/device/K242661
Methodology: https://510kreport.com/methodology