K141886

Substantially Equivalent

MDK HANDPIECES

Applicant
Modern Korea Co., Ltd.
Product code
EFB
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fullerton, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB
Injury
133
Malfunction
562
Total
695

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.