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510(k) Data Aggregation

    K Number
    K982088
    Device Name
    AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-09-04

    (81 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists. This device is intended for single use only.
    Device Description
    Affirm Smart Releasable Force Module and Trade Name: Compliance Science™
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    K Number
    K980436
    Device Name
    CLASS III REVERSE PULL FACEMASK
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-27

    (82 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is to be used to provide anchorage in Class 3 malocclusion case treatment.
    Device Description
    Class III+™ Reverse Pull Facemask
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    K Number
    K980245
    Device Name
    NITOM LOCKING FACEBOW
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-21

    (88 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists.
    Device Description
    Not Found
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    K Number
    K980864
    Device Name
    POWER COINS GLOW IN THE DARK LIGATURES
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-20

    (46 days)

    Product Code
    ECI
    Regulation Number
    872.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.
    Device Description
    Not Found
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    K Number
    K980151
    Device Name
    RELEASABLE FORCE MODULE
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-06

    (80 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists.
    Device Description
    Self-Releasable Force Module
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    K Number
    K980195
    Device Name
    FACEBOW
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-03-11

    (50 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO KINETICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for the prescribed treatment of malocclusions by dentists.
    Device Description
    Not Found
    Ask a Question

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