Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K202786
    Device Name
    Dental Low-speed Handpieces and Accessories
    Manufacturer
    MicroP Technology (Taiwan), Inc.
    Date Cleared
    2021-09-03

    (346 days)

    Product Code
    EFB, EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroP Technology (Taiwan), Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Low-speed Handpieces and Accessories are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. Halley spray is intended to be used during routine maintenance in order to lubricate Dental Handpieces (including high and low speed) and Dental Air Motors after cleaning and prior to sterilization.
    Device Description
    The low-speed dental handpieces are hand-held instruments driven by air motor or electric motor and relevant gear mechanism, capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with a rotating spindle. The Halley Series includes several models of contra-angle handpieces, straight handpieces, and air motors. The handpieces are intended to be used by well-trained professionals in the field of general dentistry. They are reusable and some have a fiber-optic light system. They are supplied with drive power, water spray, and light through the electric or air motors connected to the tube and dental units. The low-speed handpieces are divided into 4 types: contra-andle handpieces and straight handbieces. with or without fiber-optic. The contra-angle handpieces with fiber optic have 2 models and those without fiber optic have 3 models. The straight handpieces with fiber optic have 1 model and those without fiber optic have 2 models. The handpieces are mainly made of stainless steel and must be reprocessed by the user before first use and after each use. The Halley spray is a special formulated lubricating general handpieces and air-motors. The application ensures well performance and durability for high/low-speed handpieces and air motor.
    Ask a Question
    K Number
    K173943
    Device Name
    Dental High-speed Handpiece and Accessories
    Manufacturer
    MicroP Technology (Taiwan), Inc.
    Date Cleared
    2018-07-24

    (210 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroP Technology (Taiwan), Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The Dental High-speed Handpiece Halley Series is a hand-held instrument which propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine. The main materials of the dental handpiece and accessories are stainless steel. Rotation speed range is around 330,000-390,000 rpm. Our couplings are in compliance with the Type 1, Type 3 of the recognized standard ISO 9168 Hose connectors for air driven dental handpieces, and vary with the most famous brands in the world.
    Ask a Question

    Page 1 of 1