BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM— 510(k) K121131

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K121131 for BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM, Substantially Equivalent on 2012-06-06. Applicant: Straumann USA.

Clearance details

Applicant: Straumann USA
Product code: Code DZE
Advisory panel: Dental
Date received: 2012-04-13
Decision date: 2012-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, 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.