TOOTHBRUSH WASH— 510(k) K994144

Substantially Equivalent

Cal Huech, Inc.

FDA 510(k) clearance K994144 for TOOTHBRUSH WASH, Substantially Equivalent on 2000-03-02. Applicant: Cal Huech, Inc..

Clearance details

Applicant
Cal Huech, Inc.
Product code
Code EFW
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warner Robins, GA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EFW

product code EFW
Injury
143
Malfunction
698
Total
841

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.