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510(k) Data Aggregation

    K Number
    K141839
    Device Name
    PREMIER ETCH
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2014-11-17

    (132 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
    Device Description
    Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.
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    K Number
    K132526
    Device Name
    KNIT-PAK+
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2013-11-26

    (106 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required.
    Device Description
    Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord
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    K Number
    K131212
    Device Name
    PREMIER CERAMIC PRIMER
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2013-08-26

    (119 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.
    Device Description
    Not Found
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    K Number
    K083695
    Device Name
    TRAXODENT
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2009-04-28

    (134 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K062166
    Device Name
    ENAMEL PRO
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-11-21

    (116 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
    Device Description
    Not Found
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    K Number
    K062683
    Device Name
    ENAMEL PRO VARNISH
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-11-21

    (74 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.
    Device Description
    Not Found
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    K Number
    K061997
    Device Name
    PREMIER SELF-ETCHING ENAMEL SEALANT
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-10-04

    (82 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.
    Device Description
    Not Found
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    K Number
    K061998
    Device Name
    PREMIER SELF-ETCHING BOND ENHANCER
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-10-04

    (82 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.
    Device Description
    Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents.
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    K Number
    K051866
    Device Name
    PREMIER TEMPORARY CEMENT
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2005-09-06

    (57 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.
    Device Description
    Not Found
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    K Number
    K042215
    Device Name
    RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2004-09-21

    (36 days)

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

    PREMIER DENTAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cementation of Gutta-Percha in root canal using the single cone technique.
    Device Description
    Not Found
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