LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K010416
    Device Name
    HERACERAM 75
    Manufacturer
    JELENKO CO.
    Date Cleared
    2001-03-08

    (24 days)

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

    JELENKO CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003603
    Device Name
    BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE
    Manufacturer
    JELENKO CO.
    Date Cleared
    2001-01-10

    (50 days)

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

    JELENKO CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K984164
    Device Name
    JELBOND NP
    Manufacturer
    JELENKO CO.
    Date Cleared
    1998-12-29

    (39 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    JELENKO CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds to standard types of dental porcelains in the market.
    Device Description
    Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds to standard types of dental porcelains in the market.
    Ask a Question
    K Number
    K964158
    Device Name
    JEL-40 (CODE NAME RD-0430)
    Manufacturer
    JELENKO CO.
    Date Cleared
    1996-12-13

    (58 days)

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

    JELENKO CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1