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510(k) Data Aggregation

    K Number
    K132325
    Device Name
    GUIDOR BIORESORBABLE MATRIX BARRIER
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Date Cleared
    2013-10-29

    (95 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNSTAR AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GBR Configurations: To aid in bone regeneration and augmentation in oral surgery for: Extraction socket site preservation; Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire; Ridge augmentation; Sinus elevation; Stable barrier for the containment of bone grafting materials. GTR Configurations: To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for: Class II furcations; intrabony defects; recession type defects.
    Device Description
    The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix.
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    K Number
    K102053
    Device Name
    BUTLER CALCI-FLOR PROPHYLAXIS PASTE
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Date Cleared
    2011-02-03

    (196 days)

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

    SUNSTAR AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Butler® Calci-Flor Prophylaxis Paste is designed to clean and polish teeth during professionally administered dental hygiene prophylaxis treatments. Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
    Device Description
    Butler® Calci-Flor Prophylaxis Paste is an oral cavity abrasive polishing agent that contains calcium and fluoride. This device is regulated by FDA as a Class I device. Butler® Calci-Flor Prophylaxis Paste is an abrasive oral prophylaxis paste (available in one of several levels of grit coarseness), which contains fluoride, calcium, humectants, bulking agents for proper paste formation, a sweetener, flavor, color, and preservatives. This device is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to remove stain from and polish the teeth. Paste application is designed for use with a prophy angle with suitable cup. The device is to be limited to individuals who are professionally trained to perform dental prophylaxis.
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