# K172352: TREFOIL System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Oct 20, 2017 after 78 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 for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: - Adequate quantity of bone (minimum height of 13 mm for 11.5 mm implant and 14.5 mm for 13.0 implant and minimum width of 6-7 mm). - 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/K172352
Methodology: https://510kreport.com/methodology