LogoFDA 510(k) Search
Search Filters

Search Results

Found 25 results

510(k) Data Aggregation

    K Number
    K012303
    Device Name
    JEL-20
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2001-08-22

    (33 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.
    Device Description
    Jel-20 is a white Type III Crown & Bridge alloy.
    Ask a Question
    K Number
    K002993
    Device Name
    HERACERAM
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-11-16

    (52 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002645
    Device Name
    JEL BIOS PURE
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-10-19

    (56 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002222
    Device Name
    RD-2104
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-08-31

    (38 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001360
    Device Name
    SIGNUM
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-06-20

    (53 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001260
    Device Name
    ALLROUND 55 LF
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-05-17

    (28 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001196
    Device Name
    JEL BIOS 90 (CODE NAME RD-2401)
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-05-11

    (29 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000213
    Device Name
    JELDENT BASIC LINE
    Manufacturer
    J.F. JELENKO & CO.
    Date Cleared
    2000-04-06

    (73 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000532
    Device Name
    JEL 15
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2000-04-06

    (49 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993136
    Device Name
    JEL BIOS 10 (CODE NAME RD-1801)
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    1999-10-21

    (31 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **J.F. JELENKO **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
    Device Description
    High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
    Ask a Question

    Page 1 of 3