K254283
- 510(k) number
- K254283
- Device name
- BruxZir® Shaded 16 PLUS
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2026-01-30
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K254283.pdf
Official FDA record: K254283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.