Cleared Traditional

MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS

K020776 · Coronet Group North America, LLC · Dental

Jun 2002

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K020776 is an FDA 510(k) clearance for the MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Coronet Group North America, LLC (Queensbury,, US). The FDA issued a Cleared decision on June 3, 2002, 84 days after receiving the submission on March 11, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number	K020776 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2002
Decision Date	June 03, 2002
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF