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510(k) Data Aggregation

    K Number
    K053329
    Device Name
    KORLEX-GR GINGIVAL RETRACTION PASTE
    Manufacturer
    BIOTECH ONE, INC.
    Date Cleared
    2006-02-15

    (76 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTECH ONE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.
    Device Description
    Not Found
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    K Number
    K040650
    Device Name
    BONAMATES SERIES
    Manufacturer
    BIOTECH ONE, INC.
    Date Cleared
    2004-06-03

    (84 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTECH ONE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
    Device Description
    BONAMATES® Series
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