K252446
- 510(k) number
- K252446
- Device name
- BruxZir® NOW
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2025-09-03
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K252446.pdf
Official FDA record: K252446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.