Geo Abutment— 510(k) K242978

Substantially Equivalent

Geomedi Co,., Ltd.

FDA 510(k) clearance K242978 for Geo Abutment, Substantially Equivalent on 2025-06-16. Applicant: Geomedi Co,., Ltd..

Clearance details

Applicant: Geomedi Co,., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2024-09-26
Decision date: 2025-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uiwang-Si, 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.