K251232
- 510(k) number
- K251232
- Device name
- MegaGen Zygoma Dental Implant System
- Applicant
- Megagen Implant Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2026-06-18
- Date received
- 2025-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K251232.pdf
Official FDA record: K251232
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.