FDA · official record K021383Substantially Equivalent

ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL

Name: ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL — FDA K021383
Creator: Agion Technologies, LLC
Keywords: ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, K021383, EFW, FDA

United StatesEFWAgion Technologies, LLC

Verified

Official record identity

FDA application number: K021383
Decision date: July 17, 2002
Published decision: Substantially Equivalent

Classification

Product code: EFW

Published parties

Applicant: Agion Technologies, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-05-02
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6855

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.