# K151916: TRI Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Tri Dental Implants Int. AG
- Decided: Dec 18, 2015 after 158 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: 9 generations back to K894595 (1990). 41 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101880: Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant, Zimmer Dental, Inc. (2010) Summary page 4.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 4.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 4.

## Most influential descendants
- K203660: TRI-matrix Implant Line (2021), 3 descendants of its own
- 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® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System 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 Dental Implant System 6.5 mm implants are intended for delayed loading only.

Source page: https://510kreport.com/device/K151916
Methodology: https://510kreport.com/methodology