K232726
- 510(k) number
- K232726
- Device name
- External Hex Implant System
- Applicant
- Southern Implants (Pty), Ltd. ZA
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-04-01
- Date received
- 2023-09-06
- 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: K232726.pdf
Official FDA record: K232726
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.