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510(k) Data Aggregation

    K Number
    K212353
    Device Name
    DB-EZ Bone Void Filler
    Manufacturer
    Dimensional Bioceramics, LLC.
    Date Cleared
    2021-09-22

    (55 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dimensional Bioceramics, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    DB-EZ Bone Void Filler is a pre-mixed moldable and biocompatible putty/paste bone void filler. DB-EZ consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process.
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