K240232
- 510(k) number
- K240232
- Device name
- EK D3.3 and Ultra Wide Implants
- Applicant
- Hiossen, Inc. PA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-09-13
- Date received
- 2024-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240232.pdf
Official FDA record: K240232
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.