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510(k) Data Aggregation

    K Number
    K230529
    Device Name
    HealiAid Dental Collagen Wound Dressing
    Manufacturer
    Maxigen Biotech Inc.
    Date Cleared
    2023-11-22

    (268 days)

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

    Maxigen Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including: 1. Denture sores 2. Oral ulcers (non-infected or viral) 3. Periodontal surgical wounds 4. Extraction sites 5. Surgical wounds. 6. Traumatic wounds
    Device Description
    The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.
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