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510(k) Data Aggregation

    K Number
    K990314
    Device Name
    MULTI-CURE COMPOSITE CEMENT
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1999-04-02

    (60 days)

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

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis-GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.
    Device Description
    Multi-Cure Composite Cement. The base paste and catalyst paste when mixed together form an exothermic reaction. When a standard dental curing light in the visible wave-length range is used it will cause the camphorquinone and the liquid "A" dimethylaminoethyl methacrylate to accelerate this reaction.
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    K Number
    K983018
    Device Name
    ZINC PHOSPHATE CEMENT
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-10-22

    (55 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
    Device Description
    Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
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    K Number
    K982779
    Device Name
    MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-09-30

    (54 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.
    Device Description
    Not Found
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    K Number
    K982191
    Device Name
    CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-09-14

    (84 days)

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

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.
    Device Description
    Chemical Cure Composite with Enamel Bond
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    K Number
    K980990
    Device Name
    POLYCARBOXYLATE CEMENT
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-07-31

    (136 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.
    Device Description
    Polycarboxylate Cement
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    K Number
    K973919
    Device Name
    CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1997-12-16

    (62 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.
    Device Description
    Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
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    K Number
    K973541
    Device Name
    MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1997-11-25

    (68 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENTAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.
    Device Description
    Chemically Activated Pit and Fissure Sealant
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