3I T3(R) EXTERNAL HEX DENTAL IMPLANTS— 510(k) K133049

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K133049 for 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS, Substantially Equivalent on 2014-01-08. Applicant: Biomet 3i.

Clearance details

Applicant: Biomet 3i
Product code: Code DZE
Advisory panel: Dental
Date received: 2013-09-27
Decision date: 2014-01-08
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.