BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COE-SIL

    K Number: K792428 · Decision Jan 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    20
    Review Days
    57

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    Basic Information

    Device Name
    COE-SIL
    K Number
    K792428
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Coe Laboratories, Inc.
    Date Received
    November 27, 1979
    Decision Date
    January 23, 1980
    Product Code
    LDG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LDG Kit, Earmold, Impression

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    K891140 OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
    K885010 TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
    K881422 COE PAK AUTO MIX, REGULAR OR HARD SET
    K881091 OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL
    K863882 OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
    K842877 ABSOLUTE VINYL POLYSILOXANE IMPRESS
    K844325 COE-LITE POLYMERIZATION UNIT
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