# K152093: NobelZygoma 45°

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 16, 2016 after 232 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: 3 generations back to K925771 (1993). 13 ancestors in all.
3 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)
- K070182: Zygoma Implant (Immediate Function), Nobel Biocare AB (2007) Summary page 4.

## Most influential descendants
- K161598: NobelZygoma 0° (2017), 2 descendants of its own
- K243834: NobelZygoma TiUltra Implant system (2025), 0 descendants of its own
- K183069: NobelZygoma 0° (2018), 0 descendants of its own

## Indications for use
Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

Source page: https://510kreport.com/device/K152093
Methodology: https://510kreport.com/methodology