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510(k) Data Aggregation
K Number
K023662Device Name
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
Manufacturer
HWADONG INTERNATIONAL COMPANY LTD.
Date Cleared
2003-05-28
(209 days)
Product Code
MCF
Regulation Number
872.6855Why did this record match?
Product Code :
MCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proSonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.
Device Description
The proSonic Ultraviolet Toothbrush Sanitizer unit sanitizes toothbrushes hung inside the unit by reducing the amount of bacteria that accrues on them under normal conditions of use. Sanitization is accomplished via ultraviolet (UV) radiation produced by a UV lamp housed within the unit. When activated, the proSonic Ultraviolet Toothbrush Sanitizer completes an initial sanitization cycle in one (1) hour. Afterwards, a built-in timer in the unit alternately causes the UV lamp to be turned off for sixty (60) minutes and turned on for five (5) minutes in between brushing cycles. Depending on usage, the UV lamp will typically be activated for approximately one hundred-sixty five (165) minutes per day. The bulb has an effective Iife of ten thousand (10,000) hours. The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed, and the level of ozone emitted by the sanitizer is within FDA regulatory limits. The proSonic Ultraviolet Toothbrush Sanitizer is sold with four (4) accompanying toothbrushes and a power handgrip (which converts the toothbrushes into powered toothbrushes).
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K Number
K021258Device Name
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
Manufacturer
GERM TERMINATOR CORPORATION
Date Cleared
2002-05-10
(21 days)
Product Code
MCF
Regulation Number
872.6855Why did this record match?
Product Code :
MCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."
Device Description
The Germ Terminator uses steam heat to sanitize two manual toothbrushcs or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle.
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K Number
K003517Device Name
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
Manufacturer
OTRES, LLC.
Date Cleared
2001-06-06
(204 days)
Product Code
MCF
Regulation Number
872.6855Why did this record match?
Product Code :
MCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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