TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment— 510(k) K220562

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K220562 for TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment, Substantially Equivalent on 2022-11-10. Applicant: Megagen Implant Co., Ltd..

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2022-02-28
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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.