# K183069: NobelZygoma 0°

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare AB
- Decided: Dec 4, 2018 after 29 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: 5 generations back to K925771 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161598: NobelZygoma 0°, Nobel Biocare AB (2017) Summary page 4.

## Indications for use
NobelZygoma 0° 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 NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K183069
Methodology: https://510kreport.com/methodology