FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA— 510(k) K994376

Substantially Equivalent

Friadent GmbH

FDA 510(k) clearance K994376 for FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA, Substantially Equivalent on 2000-03-24. Applicant: Friadent GmbH.

Clearance details

Applicant: Friadent GmbH
Product code: Code DZE
Advisory panel: Dental
Date received: 1999-12-27
Decision date: 2000-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

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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.