3i T3 Short Implants— 510(k) K150571

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K150571 for 3i T3 Short Implants, Substantially Equivalent on 2015-11-20. Applicant: Biomet 3i.

Clearance details

Applicant: Biomet 3i
Product code: Code DZE
Advisory panel: Dental
Date received: 2015-03-06
Decision date: 2015-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, 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.