ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION— 510(k) K112730

Substantially Equivalent

Biomet 3i

FDA 510(k) clearance K112730 for ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION, Substantially Equivalent on 2012-01-13. Applicant: Biomet 3i.

Clearance details

Applicant: Biomet 3i
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-09-20
Decision date: 2012-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, US

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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.