K240383
- 510(k) number
- K240383
- Device name
- Highness Implant System
- Applicant
- Highness Co., Ltd. KR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-10-31
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240383.pdf
Official FDA record: K240383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.