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510(k) Data Aggregation
K Number
K181691Device Name
High-speed air turbine handpiece / Low-speed air turbine handpiece
Manufacturer
Foshan Wenjian Medical Instrument Co., Ltd.
Date Cleared
2020-05-26
(699 days)
Product Code
EFB, EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Foshan Wenjian Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ-142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations and polishing teeth.
Device Description
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162.
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422
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