MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS— 510(k) K020776

Substantially Equivalent

Coronet Group North America, LLC

FDA 510(k) clearance K020776 for MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS, Substantially Equivalent on 2002-06-03. Applicant: Coronet Group North America, LLC.

Clearance details

Applicant
Coronet Group North America, LLC
Product code
Code EFW
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Queensbury,, NY, 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.