BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

    K Number: K181604 · Decision Nov 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    2
    Review Days
    162

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
    K Number
    K181604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hrs Co., Ltd.
    Date Received
    June 19, 2018
    Decision Date
    November 28, 2018
    Product Code
    ELW
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELW Material, Impression

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ELW), ordered by most recent decision date.

    Dia-X Sil Bite

    FDA 510(k)
    FDA Class 2 ·Dental

    Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);

    FDA 510(k)
    FDA Class 2 ·Dental

    JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

    FDA 510(k)
    FDA Class 2 ·Dental

    Elastic Impression Material

    FDA 510(k)
    FDA Class 2 ·Dental

    Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

    FDA 510(k)
    FDA Class 2 ·Dental

    Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Hrs Co., Ltd.

    K Number Device Name
    K132869 SILDENT