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510(k) Data Aggregation

    K Number
    K113282
    Device Name
    CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
    Manufacturer
    RIEMSER ARZEIMITTEL AG
    Date Cleared
    2012-09-20

    (318 days)

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

    RIEMSER ARZEIMITTEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CERASORB® CLASSIC and CERASORB® M are recommended for: -Augmentation or reconstructive treatment of the alveolar ridge - -Filling of infrabony periodontal defects - -Filling of defects after root resection, apicoectomy, 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 perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) CERASORB® Perio is recommended for: -Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of infrabony periodontal defects - -Filling of single-or multi-wall bone pockets -Filling of bifurcations and trifurcations
    Device Description
    CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%). The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone. CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
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