BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Grafting Material, For Dental Bone Repair

    PMA: P800035 · Supplement: S011 · Decision Dec 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Bone Grafting Material, For Dental Bone Repair
    Trade Name
    CERASORB DENTAL
    PMA Number
    P800035
    Supplement Number
    S011
    Device Class
    FDA Class 2
    Product Code
    LPK
    Generic Name
    Bone grafting material, for dental bone repair
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 8, 2003
    Date Received
    April 5, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN CHANGES, A TRADE NAME CHANGE, AND NEW MANUFACTURING SITES. THIS APPROVAL ALSO ACKNOWLEDGES THAT OWNERSHIP HAS BEEN TRANSFERRED FROM MITER, INC. TO CURASAN AG. CERASORB DENTAL WILL BE MANUFACTURED AT TWO NEW FACILITIES LOCATED AT CURASAN AG, GERMANY AND WILLY RUSCH AG, GERMANY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERASORB DENTAL AND IS INDICATED FOR DEFECTS AFTER EXTIRPATION OF DENTAL ALVEOLAR CYSTS; REPAIR OF MARGINAL AND PERIAPICAL PERIODONTAL ALVEOLAR BONY POCKETS AS WELL AS BIFURCATIONS AND TRIFURCATIONS OF THE TEETH; AUGMENTATION OF THE ATROPHIED ALVEOLAR RIDGE; ALVEOLAR AUGMENTATION OF MANDIBULAR AND MAXILLARY RIDGES; DEFECTS AFTER APICOECTOMY; AND FILLING BONE DEFECTS AFTER SURGICAL RESECTION OF IMPACTED TEETH (WITHOUT IMPLANTATION).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPK Bone Grafting Material, For Dental Bone Repair