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510(k) Data Aggregation
K Number
K022900Device Name
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
Manufacturer
JOHN O. BUTLER CO.
Date Cleared
2002-11-14
(72 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Applicant Name (Manufacturer) :
JOHN O. BUTLER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.
Device Description
The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.
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K Number
K974761Device Name
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
Manufacturer
JOHN O. BUTLER CO.
Date Cleared
1998-06-16
(179 days)
Product Code
EFW
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
JOHN O. BUTLER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interdental Toothbrush Antibacterial The Butler intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.
Device Description
Butler Antibacterial Interdental Toothbrush
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