Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151209
    Device Name
    InterOss
    Manufacturer
    SigmaGraft, Inc
    Date Cleared
    2015-11-06

    (184 days)

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

    SigmaGraft, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterOss® small granules are recommended for: - 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 conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - . Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) InterOss® large granules are recommended for: - . Augmentation or reconstructive treatment of the alveolar ridge - . Elevation of the maxillary sinus floor - . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
    Device Description
    InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. InterOss® is available in granule form and is packaged in vials or a syringe-like applicator. InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm). InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm). The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting. During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes. All InterOss® products are supplied sterile and are intended for single use only.
    Ask a Question

    Page 1 of 1