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510(k) Data Aggregation
K Number
K021383Device Name
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
Manufacturer
AGION TECHNOLOGIES, LLC.
Date Cleared
2002-07-17
(76 days)
Product Code
EFW
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
AGION TECHNOLOGIES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
Device Description
The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
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