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510(k) Data Aggregation

    K Number
    K100695
    Device Name
    COLLADENTAL BARRIER
    Manufacturer
    COLLAMATRIX, INC
    Date Cleared
    2013-01-03

    (1029 days)

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

    COLLAMATRIX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaDental barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.
    Device Description
    CollaDental Barrier is a nonfriable, resorbable membrane made of purified type I collagen derived from pig skin using standardized controlled manufacturing process. The collagen is obtained from veterinary certified pigs and purified to avoid its antigenicity. The manufacturing process complies with the standards for virus inactivation. The CollaDental Barrier has been tested for purity using standard purity testing procedures, sterlized by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site.
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    K Number
    K093351
    Device Name
    COLLAWOUND ART
    Manufacturer
    COLLAMATRIX, INC
    Date Cleared
    2010-06-16

    (232 days)

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

    COLLAMATRIX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including: - partial and full thickness wounds . - pressure ulcers . - venous ulcers . - diabetic ulcers . - . chronic vascular ulcers - tunneled/undermined wounds . - surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence) - trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) . - draining wounds .
    Device Description
    CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.
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