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

    JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD

    K Number: K100653 · Decision Oct 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    9
    Review Days
    214

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    Basic Information

    Device Name
    JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
    K Number
    K100653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lang Dental Mfg. Co., Inc.
    Date Received
    March 8, 2010
    Decision Date
    October 8, 2010
    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 Lang Dental Mfg. Co., Inc.

    K Number Device Name
    K112397 ORTHO-JET CRYSTAL
    K083195 MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
    K081981 LANG DENTAL ACRYLIC PRIMER
    K081514 TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
    K081705 LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
    K072580 JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23
    K972553 LANG DENTAL RESIN A97 FIBRED PINK
    K941925 ORTHO-JET ACRYLIC RESIN - SPARKLE