DYNA IMPLANT DESIGN— 510(k) K930868

Substantially Equivalent

Dyna Dental Engineering BV

FDA 510(k) clearance K930868 for DYNA IMPLANT DESIGN, Substantially Equivalent on 1995-04-28. Applicant: Dyna Dental Engineering BV.

Clearance details

Applicant
Dyna Dental Engineering BV
Product code
Code DZE
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
2594 Ac Den Haag-Holland, NU
Download summary PDFView on FDA.gov ↗

Adverse events under product code DZE

product code DZE
Death
28
Injury
3,367,041
Malfunction
19,958
Other
13
Total
3,387,040

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.