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510(k) Data Aggregation

    K Number
    K090793
    Device Name
    BONGROS HA
    Manufacturer
    Date Cleared
    2009-05-19

    (56 days)

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

    BIOALPHA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery. The products may be used in surgical procedures such as: · Augmentation or reconstructive treatment of the alveolar ridge · Filling of extraction sockets to enhance preservation of the alveolar ridge · Elevation of the maxillary sinus floor · Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
    Device Description
    Bongros®-HA is made of highly pure, synthetic hydroxyapatite (Ca10(PO4)6(OH)2). Bongros®-HA has trabecular structure that resembles the 3-dimensional interconnected pore structure of human cancellous bone. When Bongros -HA is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with hard tissue. Bone formation occurs in apposition to the Bongros® HA surface and within the interstices of the implant skeleton. Bongros -HA have three specific models which are HAGS, HAGM and HAGL. The quality of the material of HAGS, HAGM and HAGL is equal but only the sizes of each model are different from each other. Therewith, Bongros®-HA is provided sterile for single use.
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