K231578
- 510(k) number
- K231578
- Device name
- Lucitone Digital Print Denture System
- Applicant
- Dentsply Sirona PA · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2023-10-20
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K231578.pdf
Official FDA record: K231578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.