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510(k) Data Aggregation

    K Number
    K983104
    Device Name
    NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
    Manufacturer
    NORIAN CORP.
    Date Cleared
    1999-02-12

    (161 days)

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

    NORIAN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
    Device Description
    Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.
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    K Number
    K973789
    Device Name
    NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
    Manufacturer
    NORIAN CORP.
    Date Cleared
    1998-05-18

    (224 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORIAN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Norian CRS is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
    Device Description
    Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution. When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed. The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.
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