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510(k) Data Aggregation

    K Number
    K990448
    Device Name
    THE.R.MO.FREE
    Manufacturer
    DENTAMAX, INC.
    Date Cleared
    1999-03-23

    (39 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAMAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication or repair of bases for partial or full dentures.
    Device Description
    Not Found
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    K Number
    K983558
    Device Name
    ACETAL DENTAL/PREFORMED CLASP
    Manufacturer
    DENTAMAX, INC.
    Date Cleared
    1999-01-07

    (86 days)

    Product Code
    EHP, OCT
    Regulation Number
    872.3285
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAMAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.
    Device Description
    Acetal Dental / Preformed Clasp
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