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510(k) Data Aggregation
K Number
K193264Device Name
Disposable High Speed Air Turbine Handpiece
Manufacturer
Date Cleared
2020-08-11
(259 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Ningbo HPDOVE Dental Instruments Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable high speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
The disposable high-speed air turbine handpiece is an air-driven dental handpiece for the use by a trained professional in the field of general dentistry. The device is an ergonomically shaped air-powered handpiece that is disposable. The device features a 4-pin (drive air, exhaust air, spray air and spray water holes) connector for air and water input and return. A water/air mist cools the head and bur. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine.
The disposable high-speed air turbine dental handpiece is an instrument widely applied in oral therapy. It is composed of interrelated parts, working as a complete set. The disposable high-speed air turbine dental handpiece is an air-driven handpiece which supplied with water and air through the pipe and the coupling of a dental treatment unit. The device contains air and water pipes inside which supply air for driving the turbine assembly rotating and cooling water for work site as well as supply air and water for creating spray. The air-driven turbine assembly provides rotation to the bur for removing carious material, excess filling material, cavity, and is used for crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The handpiece is supplied non-sterile and must be cleaned and sterilized before use.
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