Multi-unit Abutment, Multi-unit Angled Abutment— 510(k) K203808

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K203808 for Multi-unit Abutment, Multi-unit Angled Abutment, Substantially Equivalent on 2021-10-20. Applicant: Megagen Implant Co., Ltd..

Clearance details

Applicant
Megagen Implant Co., Ltd.
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Daegu, KR
Download summary PDFView 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, through . 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.