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510(k) Data Aggregation
K Number
K111465Device Name
COMPOTHIXO
Manufacturer
Date Cleared
2012-07-25
(426 days)
Product Code
Regulation Number
872.4565Why did this record match?
Applicant Name (Manufacturer) :
KERRHAWE SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.
Device Description
Compothixo is a hand-held, battery-operated, vibration composite modeling instrument. When the device is turned on the unit begins to vibrate at 140 Hz. It functions in the same way as a hand-operated composite modeling instrument, and also has interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW. Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status. The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.
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