BellaTek Encode Emergence Healing Abutments— 510(k) K212730

Substantially Equivalent

Biomet 3i, LLC

FDA 510(k) clearance K212730 for BellaTek Encode Emergence Healing Abutments, Substantially Equivalent on 2021-12-21. Applicant: Biomet 3i, LLC.

Clearance details

Applicant: Biomet 3i, LLC
Product code: Code NHA
Advisory panel: Dental
Date received: 2021-08-30
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Special
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.