# K170135: TREFOIL System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: May 11, 2017 after 114 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: 2 generations back to K000018 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152836: TREFOIL System, Nobel Biocare AB (2016) Summary page 4.

## Indications for use
The Trefoil system is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: - Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant). - Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. - Implant-supported prosthetics seated directly on dedicated implants.

Source page: https://510kreport.com/device/K170135
Methodology: https://510kreport.com/methodology