K233859
- 510(k) number
- K233859
- Device name
- BASIS FLOW II
- Applicant
- YAMAHACHI DENTAL MFG., Co. JP
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2024-03-05
- Date received
- 2023-12-06
- 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: K233859.pdf
Official FDA record: K233859
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.