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510(k) Data Aggregation
K Number
K222548Device Name
Endo Motor
Manufacturer
Shenzhen Perfect Medical Instruments Co., Ltd.
Date Cleared
2023-04-26
(246 days)
Product Code
EKX, LOY, LQY
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Perfect Medical Instruments Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring 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.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
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