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510(k) Data Aggregation

    K Number
    K180682
    Device Name
    AeroPro Cordless Prophy System
    Manufacturer
    Premier Dental Company Products
    Date Cleared
    2019-02-27

    (349 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Premier Dental Company Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.
    Device Description
    AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.
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    K Number
    K161580
    Device Name
    Premier Sealant
    Manufacturer
    PREMIER DENTAL COMPANY PRODUCTS
    Date Cleared
    2016-10-18

    (132 days)

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

    PREMIER DENTAL COMPANY PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
    Device Description
    Not Found
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    K Number
    K150601
    Device Name
    Zeramic Adhesive Resin Cement
    Manufacturer
    Premier Dental Company Products
    Date Cleared
    2015-07-22

    (134 days)

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

    Premier Dental Company Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.
    Device Description
    Not Found
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