# K203660: TRI-matrix Implant Line

- Pathway: 510(k) (Traditional)
- Applicant: Tri Dental Implants Int. AG
- Decided: Dec 21, 2021 after 371 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: 15 generations back to K894595 (1990). 177 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151916: TRI Dental Implant System, Tri Dental Implants Int. AG (2015) Summary page 4.
- K172225: Atlantis Abutment for MIS Implant, Dentsply Sirona (2017) Summary page 4.

## Most influential descendants
- K242661: TRI-matrix® X-Force Implants (2025), 0 descendants of its own
- K241170: Dynamic TiBase; TRI Screws (2024), 0 descendants of its own
- K233231: Dental Implants and Abutments (2024), 0 descendants of its own

## Indications for use
The TRI-matrix® Implant Line is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® Implant Line allows 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® Implant Line 6.5 mm implants are intended for delayed loading only. The TRI-matrix® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the TRI-matrix® Crown Abutment to the endosseous implant.

Source page: https://510kreport.com/device/K203660
Methodology: https://510kreport.com/methodology