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510(k) Data Aggregation
K Number
K141482Device Name
KI-20
Manufacturer
Date Cleared
2015-04-24
(324 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SAEYANG MICROTECH CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.
Device Description
The Ki-20 is designed to use in dental surgery. It consists of an E-type motor (DC 28V Operation Motor), handpieces, a control box, a foot switch and other accessories. It is designed that the speed and direction of the handpiece can be controlled by the control box and the foot switch. The irrigation tube and the pump are used to supply the cooling water for the successful surgery.
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