CERTAIN BELLATEK PROVISIONAL ABUTMENTS— 510(k) K130310

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K130310 for CERTAIN BELLATEK PROVISIONAL ABUTMENTS, Substantially Equivalent on 2013-06-21. Applicant: Biomet 3i.

Clearance details

Applicant: Biomet 3i
Product code: Code NHA
Advisory panel: Dental
Date received: 2013-02-07
Decision date: 2013-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.