Cleared Traditional

ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL

K021383 · Agion Technologies, LLC · Dental

Jul 2002

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K021383 is an FDA 510(k) clearance for the ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Agion Technologies, LLC (Wakefield, US). The FDA issued a Cleared decision on July 17, 2002, 76 days after receiving the submission on May 2, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number	K021383 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2002
Decision Date	July 17, 2002
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF