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K Number
K191276Device Name
Dental Electrical Motor iRoot Pro
Manufacturer
ChangZhou BoMedent Medical Technology Co., Ltd.
Date Cleared
2020-06-30
(414 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ChangZhou BoMedent Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
Device Description
The Dental Electrical Motor iRoot Pro is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by USB interface. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization and calibration. The product also provides a complete rotation mode and root canal measurement mode, which can be stored in memory, and provides a key functional mode for users to use quickly.
The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
The Dental Electrical Motor iRoot Pro is intended to be sterilized prior to use.
There are four working modes as:
Mode: Only endo motor function enabled;
Mode: Endo motor and apex locator work independently, when the file reaching theapical, the apex locator only plays the role of warning and display, will not interfere with the rotation of endo motor, the motor will not stop and reverse when the file reach the apical.
Mode: In this mode, the motor will automatically rotate, stop, reverse depends on the length of the root canal measured by the apex locator.
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