K240574
- 510(k) number
- K240574
- Device name
- BruxZir® Radiant
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-03-20
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240574.pdf
Official FDA record: K240574
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.