DeviceClearance

K935542

Substantially Equivalent

NICKEL-TITANIUM K-TYPE FILE

Applicant
Union Broach, Div. Moyco Industries, Inc.
Product code
EKS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Emigsville, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EKS

product code EKS
Malfunction
1,949
Total
1,949

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.