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510(k) Data Aggregation

    K Number
    K014133
    Device Name
    PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2002-03-14

    (87 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
    Device Description
    PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
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    K Number
    K014138
    Device Name
    PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2002-03-14

    (87 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces
    Device Description
    PULPDENT Triple-Cure™ Reinforced Glass lonomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the of thouonic cement that ban be dood as a bracked as a brache of early of the edire" ("" (" is a fluoride releasing, light-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces.
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    K Number
    K020115
    Device Name
    PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2002-02-28

    (48 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
    Device Description
    PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
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    K Number
    K014059
    Device Name
    PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2002-02-27

    (79 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel to adhere orthodontic brackets to tooth surfaces.
    Device Description
    PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel.
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    K Number
    K013411
    Device Name
    PULPDENT CAVITY PREPARATION IV
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2001-12-12

    (58 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent Cavity Preparation IV is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this "cleansing" step reduces micro leakage and sensitivity in teeth undergoing treatment or restorations. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.
    Device Description
    Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces.
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    K Number
    K994180
    Device Name
    PULPDENT CAVITY PREPARATION III
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2000-03-02

    (83 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent Cavity Preparation III is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparations III, a solution of glutaraldehyde and water, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.
    Device Description
    Pulpdent Cavity Preparations III, a solution of glutaraldehyde and water, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution.
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    K Number
    K994181
    Device Name
    PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2000-02-29

    (81 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate. Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.
    Device Description
    Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules.
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    K Number
    K994182
    Device Name
    PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    2000-02-23

    (75 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent Cavity Preparation I is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation I, an aqueous solution of the disodium salt of ethylenediaminetetraacetic acid dihydrate and benzalkonium chloride, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of benzalkonium chloride. Pulpdent Cavity Preparation I with Fluoride has the advantage of increased stability from the addition of sodium fluoride. Pulpdent makes no therapeutic claim with regard to the addition of sodium fluoride.
    Device Description
    Pulpdent Cavity Preparation I, an aqueous solution of the disodium salt of ethylenediaminetetraacetic acid dihydrate and benzalkonium chloride
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    K Number
    K993683
    Device Name
    PULPDENT UNO-DUO
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    1999-12-13

    (42 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a singlecomponent light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.
    Device Description
    PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNC-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which helshe prefers a self-cure or dual cure product.
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    K Number
    K974202
    Device Name
    PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    1998-03-19

    (129 days)

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

    PULPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.
    Device Description
    Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration. Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.
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