K240560
- 510(k) number
- K240560
- Device name
- ZENEX Implant System_Long
- Applicant
- Izenimplant Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-10-30
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240560.pdf
Official FDA record: K240560
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.