K243336
- 510(k) number
- K243336
- Device name
- Lucitone Digital Print Denture System
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2024-12-17
- Date received
- 2024-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243336.pdf
Official FDA record: K243336
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.