# K151909: Noris Medical Zygomatic Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Apr 8, 2016 after 270 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: 16 generations back to K960026 (1996). 259 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093562: Endosseous Dental Implant, Southern Implants, Inc. (2010) Summary page 4.
- K140440: Noris Medical Dental Implants System, Noris Medical, Ltd. (2014) Summary page 4.

## Most influential descendants
- K173343: Zygomatic Implant System (2018), 2 descendants of its own
- K210356: Noris Medical Dental Implants System (2022), 1 descendant of its own
- K192651: ZAGA Zygomatic System (2020), 1 descendant of its own
- K251232: MegaGen Zygoma Dental Implant System (2026), 0 descendants of its own
- K252031: Adin Long Dental Implant System (2026), 0 descendants of its own

## Indications for use
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient’s chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.

Source page: https://510kreport.com/device/K151909
Methodology: https://510kreport.com/methodology