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Found 6 results

510(k) Data Aggregation

    K Number
    K014249
    Device Name
    JETPOLISHER
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-02-19

    (55 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JETPOLISHER airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets
    Device Description
    Not Found
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    K Number
    K014252
    Device Name
    JETSTREAM
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-02-19

    (55 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JETSTREAM airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
    Device Description
    JETSTREAM airpolishing unit
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    K Number
    K014245
    Device Name
    JETSONIC 2000
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-01-29

    (34 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JETSONIC 2000 combines both scaling and airpolishing functions in one The 62100110 2000 wers all prophylaxis needs. The airpolishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler michaed to be used to be used for for fast and reliable removal of light to heavy calculus and plaque. Carculus and plaque. Device applications: Routine oral prophylaxis , routine polishing especially hard to Device applications. It enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
    Device Description
    The JETSONIC 2000 combines both scaling and airpolishing functions in one
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    K Number
    K014238
    Device Name
    DELSONIC 2000
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-01-24

    (29 days)

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

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system removal of light to h removal or light to tight to time for each scaling insert.
    Device Description
    Not Found
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    K Number
    K013969
    Device Name
    MINIBLASTER
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-01-10

    (38 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Miniblaster is an autoclavable clinical sandblaster for: - Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges. - Sandblasting to remove residual cement from crowns and bridged. . - Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs. - Sandblasting of orthodontic bands removes cement and enhances bonding. ● - Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ● - Sandblasting of all surfaces to be bonded. .
    Device Description
    Miniblaster is an autoclavable clinical sandblaster
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    K Number
    K011179
    Device Name
    DELDENT ULTRASONIC INSERTS
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2001-06-05

    (49 days)

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

    DELDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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