FotoDent denture— 510(k) K200580
Substantially EquivalentDreve Dentamid GmbH
FDA 510(k) clearance K200580 for FotoDent denture, Substantially Equivalent on 2020-11-19. Applicant: Dreve Dentamid GmbH.
Clearance details
- Applicant
- Dreve Dentamid GmbH
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Unna, DE
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.