# K161598: NobelZygoma 0°

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 14, 2017 after 278 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: 4 generations back to K925771 (1993). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152093: NobelZygoma 45°, Nobel Biocare AB (2016) Summary page 4.

## Most influential descendants
- K243834: NobelZygoma TiUltra Implant system (2025), 0 descendants of its own
- K183069: NobelZygoma 0° (2018), 0 descendants of its own

## Indications for use
NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for inmediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K161598
Methodology: https://510kreport.com/methodology