DD medical polymers (PMMA)— 510(k) K230410

Substantially Equivalent

Dental Direkt GmbH

FDA 510(k) clearance K230410 for DD medical polymers (PMMA), Substantially Equivalent on 2023-06-23. Applicant: Dental Direkt GmbH.

Clearance details

Applicant
Dental Direkt GmbH
Product code
Code EBI
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Spenge, DE
Download summary PDFView on FDA.gov ↗

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.