DeviceClearance

K897195

Substantially Equivalent

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)

Applicant
A Company, Inc.
Product code
EKS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, 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.