K231426
- 510(k) number
- K231426
- Device name
- 8plant Implant System
- Applicant
- Hoowon Edi Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-05-24
- Date received
- 2023-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231426.pdf
Official FDA record: K231426
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.