# K152836: TREFOIL System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Apr 11, 2016 after 195 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: 1 generation back to K000018 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000018: Branemark Novum, Nobel Biocare Uas, Inc. (2000) Summary page 4.

## Most influential descendants
- K172352: TREFOIL System (2017), 0 descendants of its own
- K170135: TREFOIL System (2017), 0 descendants of its own

## 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 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/K152836
Methodology: https://510kreport.com/methodology