K230438
- 510(k) number
- K230438
- Device name
- URIS Smart Path Implant System & Prosthetic
- Applicant
- Truabutment, Inc. CA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2023-12-29
- Date received
- 2023-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K230438.pdf
Official FDA record: K230438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.