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

    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

    K Number: K012882 · Decision Nov 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
    K Number
    K012882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermoelastic Technologies, Inc.
    Date Received
    August 28, 2001
    Decision Date
    November 14, 2001
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Thermoelastic Technologies, Inc.

    K Number Device Name
    K994357 BITEM LOCK, MODELS SW006, SW012