K233083
- 510(k) number
- K233083
- Device name
- Osteon Precision Milled Suprastructure
- Applicant
- Implant Solutions Pty Ltd (Aka Osteon Medical) AU
- Product code
- NHA — Abutment, Implant, Dental, Endosseous
- Decision date
- 2024-03-09
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233083.pdf
Official FDA record: K233083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.