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510(k) Data Aggregation

    K Number
    K093971
    Device Name
    DENTAL HANDPIECE
    Manufacturer
    NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.
    Date Cleared
    2010-04-22

    (119 days)

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

    NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Speed Air Turbine Handpiece series: This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology. Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece Series: This device is an air-powered hand-held device. intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.
    Device Description
    High Speed Air Turbine Handpiece series: There are two series (total 12 models) handpieces in this high speed hanhpiece series as A and B series. A series means the initial of model is "A", which include Quick Coupling, B series means the initial of model is "B", which doesn't include Quick Coupling. The High Speed Air Turbine Handpiece series device is reusable device, but they should be sterilized before use. In the A series, there are 2 models (AZL-4 and ADZ-4) device have one especial different from other model. These two model device have illumination function implemented via LED, the power supply of which is 3.3V d.c. and supplied by Therapy Machine. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device. Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series: This series devices is the low speed handpiece device which includes 2 air motors (model 0222 is two hole motor; model 0224 is four hole motor), one straight head (model 043) and one contra angle head (model 058E). the two air motor can be matched with the straight or contra angle head discretional for different condition. The Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series device is reusable device, but they should be sterilized before use. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.
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    K Number
    K080438
    Device Name
    DENTAL UNIT WITH CHAIR
    Manufacturer
    NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.
    Date Cleared
    2008-04-04

    (45 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
    Device Description
    The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168. All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.
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