# K251232: MegaGen Zygoma Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jun 18, 2026 after 422 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: 18 generations back to K960026 (1996). 261 ancestors in all.
No later device cites it as a predicate yet.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151909: Noris Medical Zygomatic Dental Implant System, Noris Medical, Ltd. (2016) Summary page 5.
- K210356: Noris Medical Dental Implants System, Noris Medical, Ltd. (2022) Summary page 5.

## Indications for use
Zygoma Dental Implant system is intended to replace missing tooth/teeth by surgical installation in the zygoma region 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. The Dental implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Zygomatic Dental Implants are intended to be implanted in the upper jaw arch to provide support for fixed on removable prosthetic devices in patients with partially or fully edentulous maxilla.

Source page: https://510kreport.com/device/K251232
Methodology: https://510kreport.com/methodology