MRI Compatibility for Existing Straumann Dental Implant Systems— 510(k) K190662

Substantially Equivalent

Straumann USA, LLC

FDA 510(k) clearance K190662 for MRI Compatibility for Existing Straumann Dental Implant Systems, Substantially Equivalent on 2019-06-17. Applicant: Straumann USA, LLC.

Clearance details

Applicant: Straumann USA, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2019-03-15
Decision date: 2019-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View 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, 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.