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

    V.R.S. DENTURE RESIN MATERIAL

    K Number: K962333 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    36
    Review Days
    51

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    Basic Information

    Device Name
    V.R.S. DENTURE RESIN MATERIAL
    K Number
    K962333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vident
    Date Received
    June 17, 1996
    Decision Date
    August 7, 1996
    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 Vident

    K Number Device Name
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    K052710 VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
    K052130 VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
    K050362 VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
    K022996 VITA IN-CERAM YZ CUBES FOR CEREC
    K012473 VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
    K000597 VITA RESPONSE
    K990367 PDQ AND PDQ-TI ABUTMENT
    K984198 WIDE BODY ABUTMENTS
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