3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix— 510(k) K212541
Substantially EquivalentDeltamed GmbH
FDA 510(k) clearance K212541 for 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix, Substantially Equivalent on 2022-01-10. Applicant: Deltamed GmbH.
Clearance details
- Applicant
- Deltamed GmbH
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Friedberg, 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.