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510(k) Data Aggregation

    K Number
    K150079
    Device Name
    Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
    Manufacturer
    Date Cleared
    2015-12-10

    (329 days)

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

    NIBEC CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table. | Format | Syringe | Plug | Block | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Indication<br>for use | - Filling of periodontal<br>defects in conjunction with<br>products intended for<br>Guided Tissue<br>Regeneration (GTR)<br><br>- Filling of peri-implant<br>defects in conjunction with<br>products intended for<br>Guided Bone Regeneration<br>(GBR) | - Filling of extraction sockets<br><br>- Augmentation or<br>reconstructive treatment of the<br>alveolar ridge<br><br>-Elevation of maxillary sinus<br>floor | - Augmentation or<br>reconstructive treatment of<br>the alveolar ridge<br><br>-Elevation of maxillary sinus<br>floor |
    Device Description
    Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenome® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
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