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510(k) Data Aggregation

    K Number
    K112574
    Device Name
    PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2012-01-23

    (139 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.
    Device Description
    Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement.
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    K Number
    K022675
    Device Name
    PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2002-11-07

    (87 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.
    Device Description
    Prime-Dent® Automix Dual Cure Core Build-Up Material
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    K Number
    K021524
    Device Name
    LIGHT CURE DENTAL DAM
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2002-07-19

    (70 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and molsture prevention/barrier.
    Device Description
    Not Found
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    K Number
    K013970
    Device Name
    PRIME-DENT HEMA DESENSITIZER
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2002-02-19

    (78 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.
    Device Description
    Not Found
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    K Number
    K012794
    Device Name
    PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2001-11-05

    (76 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.
    Device Description
    Not Found
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    K Number
    K012761
    Device Name
    PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2001-11-01

    (76 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent® Visible Light Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.
    Device Description
    Not Found
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    K Number
    K012673
    Device Name
    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2001-10-24

    (71 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste system intended for bonding plastic, metal or ceramic orthodontic brackets to etched enamel. An active archwire may be placed immediately after adhesive has properly cured.
    Device Description
    Not Found
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    K Number
    K001108
    Device Name
    PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2000-05-30

    (55 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994224
    Device Name
    PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2000-01-31

    (47 days)

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

    PRIME DENTAL MANUFACTURING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.
    Device Description
    Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.
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