THE STRAUMANN ORTHO IMPLANT SYSTEM— 510(k) K040469

Substantially Equivalent

The Straumann Co.

FDA 510(k) clearance K040469 for THE STRAUMANN ORTHO IMPLANT SYSTEM, Substantially Equivalent on 2004-04-30. Applicant: The Straumann Co..

Clearance details

Applicant: The Straumann Co.
Product code: Code OAT
Advisory panel: Dental
Date received: 2004-02-24
Decision date: 2004-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.