Flexible Partial Resin— 510(k) K250302
Substantially EquivalentPrismatik Dentalcraft, Inc.
FDA 510(k) clearance K250302 for Flexible Partial Resin, Substantially Equivalent on 2025-06-25. Applicant: Prismatik Dentalcraft, Inc..
Clearance details
- Applicant
- Prismatik Dentalcraft, Inc.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.