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510(k) Data Aggregation

    K Number
    K050260
    Device Name
    BIORESORB MACRO PORE
    Manufacturer
    ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH
    Date Cleared
    2005-07-15

    (162 days)

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

    ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioResorb® is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.
    Device Description
    BioResorb® Macro Pore ß tricalcium phosphate is a synthetic, resorbable bone void filling material.
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