K240882
- 510(k) number
- K240882
- Device name
- BruxZir® Esthetic
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-05-01
- Date received
- 2024-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240882.pdf
Official FDA record: K240882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.