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510(k) Data Aggregation

    K Number
    K202675
    Device Name
    InRoad® Dental Synthetic Bone Graft
    Manufacturer
    Osteogene Tech Corp
    Date Cleared
    2022-03-04

    (535 days)

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

    Osteogene Tech Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmenation) - Filling of alveolar defects following tooth extraction for alveolar ridge preservation - Filling of extraction defects to create an implant bed - Filling of two- or multi- walled infra-bony pockets. and bi- and trifurcation defects - Support function for a membrane in controlled tissue regeneration (CTR) - Defects after surgical removal of retained teeth or corrective osteotomies - Other multi-walled bone defects of the alveolar processes
    Device Description
    InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense porous bioceramic for bone regeneration. It is comprised of 90 ± 5% hydroxyapatite (HA) and 10 ± 5% ß-Tricalcium Phosphate (B-TCP). The granules are provided sterile (gamma irradiated) in a capped vial packaged in a sealed tray with lid. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, a secondary channel-like structure, and tertiary small holes on the surface resulting in a biocompatible, osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental Synthetic Bone Graft is available in granule form in sizes of 0.3 - 1.0 mm (Small) and 0.8 - 1.8 mm (Large).
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