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510(k) Data Aggregation

    K Number
    K170104
    Device Name
    COMPACT S, COMPACT S (LED)
    Manufacturer
    DMETEC CO., LTD.
    Date Cleared
    2017-12-27

    (349 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - removing supra and subgingival calculus and stains - periodontal pocket lavage with simultaneous ultrasonic tip movement - scaling and root planning - releasing crowns, bridges, inlays and posts as well as condensing gutta percha - plugging for amalgam condensation - amalgam burnishing - preparing, cleanig, and irrigating root canals - preparing approximal cavites - cementing inlays and onlays - retrograde preparation of root canals
    Device Description
    The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices. The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.
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    K Number
    K121620
    Device Name
    ULTRASONIC SURGERY
    Manufacturer
    DMETEC CO., LTD.
    Date Cleared
    2012-12-11

    (193 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
    Device Description
    This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
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    K Number
    K113152
    Device Name
    ULTRASONIC SURGERY MACHINE
    Manufacturer
    DMETEC CO., LTD.
    Date Cleared
    2012-06-14

    (233 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation
    Device Description
    This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside
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    K Number
    K060171
    Device Name
    CLEANSE S+ ULTRASONIC SCALER
    Manufacturer
    DMETEC CO., LTD.
    Date Cleared
    2006-03-29

    (65 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use during dental procedures to: -Remove supra and subgingival calculus and stains - Remove ouple and Subge with simultaneous ultrasonic tip movement - Scaling and root planning - Releasing crowns, bridges, inlays and posts as well as condensing gutta percha - Plugging for amalgam condensation - Amalgam burnishing - Preparing, cleaning, and irrigating root canals - Preparing approximal cavities - Cementing inlays and onlays - Retrograde preparation of root canals
    Device Description
    The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.
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    K Number
    K051571
    Device Name
    SKYLIGHT LED CURING LIGHT
    Manufacturer
    DMETEC CO., LTD.
    Date Cleared
    2005-07-19

    (35 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skylight LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 440-490 nm waveband of visible light.
    Device Description
    Skylight by DMETEC Co., Ltd is classified as an Ultraviolet Activator for polymerization(21 C.F.R. 872.6070) because it is a device intended for the photo-polymerization light cured dental materials. The Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cif, 13-11mm light quide. These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing. The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.
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