MegaGen Zygoma Dental Implant System— 510(k) K251232
Substantially EquivalentMegagen Implant Co., Ltd.
FDA 510(k) clearance K251232 for MegaGen Zygoma Dental Implant System, Substantially Equivalent on 2026-06-18. Applicant: Megagen Implant Co., Ltd.. Device class: 2.
Summary
The MegaGen Zygoma Dental Implant System from Megagen Implant is filed under DZE, root-form endosseous implants. The record doesn't list implant lengths or models.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Megagen filed from Deagu, South Korea, as the record spells the city. The decision came 422 calendar days after FDA received it (April 22, 2025 to June 18, 2026).
Clearance details
- Applicant
- Megagen Implant Co., Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deagu, KR
Recent devices under product code DZE
view allMore clearances from Megagen Implant Co., Ltd.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.