Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231672
    Device Name
    S1
    Manufacturer
    MedPark Co., Ltd.
    Date Cleared
    2023-10-13

    (127 days)

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

    MedPark Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S1 is intended for the following uses: · Augmentation or reconstructive treatment of the alveolar ridge; - · Filling of infrabony periodontal defects - · Filling of defects after root resection, apicocectomy, and cystectomy - · Filling of extraction sockets to enhance preservation of the alveolar ridge - · Elevation of the maxillary sinus floor · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
    Device Description
    S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product. S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area. S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite. The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.
    Ask a Question

    Page 1 of 1