# K070182: Zygoma Implant (Immediate Function)

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Apr 4, 2007 after 75 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 K925771 (1993). 12 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970499: Branemark System Zygomaticus Fixture System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K050641: Zygoma Tiunite, Nobel Biocare USA, LLC (2005) Summary page 1.
- K052885: Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315, Nobel Biocare USA, LLC (2005) Summary page 1.

## Most influential descendants
- K093562: Endosseous Dental Implant (2010), 10 descendants of its own
- K141777: Neodent Implant System (2015), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K152093: NobelZygoma 45° (2016), 3 descendants of its own
- K190718: Zygomatic Implants (2019), 2 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 manual are satisfied.

Source page: https://510kreport.com/device/K070182
Methodology: https://510kreport.com/methodology