BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    enCore Impression Material

    K Number: K251926 · Decision Mar 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    enCore Impression Material
    K Number
    K251926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Guards
    Date Received
    June 23, 2025
    Decision Date
    March 17, 2026
    Product Code
    SHI
    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
    SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

    Similar 510(k) Clearances

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

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    Other Clearances by Encore Guards

    K Number Device Name
    K252004 enCore Night Guard