BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM— 510(k) K123512

Substantially Equivalent

Biodenta Swiss AG

FDA 510(k) clearance K123512 for BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM, Substantially Equivalent on 2013-03-28. Applicant: Biodenta Swiss AG.

Clearance details

Applicant: Biodenta Swiss AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2012-11-13
Decision date: 2013-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berneck, St.Gallen, CH

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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, 2020-01-01 through 2026-04-23. 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.