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510(k) Data Aggregation

    K Number
    K990060
    Device Name
    MACH 7
    Manufacturer
    KREATIV, INC.
    Date Cleared
    2000-06-15

    (524 days)

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

    KREATIV, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.
    Device Description
    The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill. The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
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    K Number
    K983227
    Device Name
    POWER BLOCK
    Manufacturer
    KREATIV, INC.
    Date Cleared
    1998-12-11

    (87 days)

    Product Code
    EIE, DAT
    Regulation Number
    872.6300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KREATIV, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.
    Device Description
    PowerBlock is a white, light reflective, paint on dam.
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    K Number
    K980216
    Device Name
    KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
    Manufacturer
    KREATIV, INC.
    Date Cleared
    1998-06-16

    (146 days)

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

    KREATIV, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.
    Device Description
    The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The units are capable of removing dental caries, old restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a high speed dental drill. The systems are designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
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    K Number
    K962376
    Device Name
    KREATIV KURING LIGHT SYSTEM
    Manufacturer
    KREATIV, INC.
    Date Cleared
    1997-03-21

    (274 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    KREATIV, INC.

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