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510(k) Data Aggregation

    K Number
    K131385
    Device Name
    EASY-GRAFT
    Manufacturer
    Degradable Solutions AG
    Date Cleared
    2013-09-27

    (136 days)

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

    Degradable Solutions AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    easy-graft™ is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial Indications may include: - . Extraction defects (alveolar ridge preservation) - Periodontal defects . - Peri-implant defects . - Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR) ・ - Sinus floor augmentation . - Defects after surgical extractions - - Defects after removal of bone cysts - Defects after root resection or apicoectorny - Defects after removal of autotogous bone .
    Device Description
    easy-graft™ contains: - Syringe containing beta-tricalcium phosphate (β-TCP) granules coated with poly(lactide-co-alvcolide) (PLGA) - Ampule containing BioLinker™ (N-methyl-2-pyrrolidone and water) . easy-graft™ is a bioresorbable, synthetic, porous bone graft substitute. It consists of two components: granules (supplied in a syringe) and BioLinker™ (supplied in an ampule). After mixing the components together, easy-graft" forms a moldable mass that can be applied directly from the syringe into the bone defect. easy-graft™ hardens in contact with body fluids, allowing a working time of approximately one minute after application into the bone defect. Depending on · blood inflow, hardening may take longer. easy-graft™ is provided in the particle sizes of 500 – 630 µm for smaller defects and 500 – 1000 um for larger defects. easy-graft™ is a biocompatible and osteoconductive material that allows for complete resorption by the body. easy-graft™ can be used in combination with dental membranes. easy-graft" contains no animal or human derived substances. β-TCP and PLGA are derived from synthetic raw materials.
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