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

    ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER

    K Number: K934248 · Decision Dec 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    32
    Review Days
    100

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    Basic Information

    Device Name
    ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
    K Number
    K934248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wallace A. Erickson & Co.
    Date Received
    August 30, 1993
    Decision Date
    December 8, 1993
    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 Wallace A. Erickson & Co.

    K Number Device Name
    K984503 ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
    K963922 ALPHA-DENT ROOT CANAL SEALER & FILLER
    K960667 CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
    K960365 ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
    K960165 ALPHA-DENT COMPOSITE SURFACE SEALANT
    K960122 ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
    K955521 ALPHA-DENT COPAL CAVITY VARNISH
    K955089 ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
    K942742 ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
    K942727 ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
    Search all 32 clearances from Wallace A. Erickson & Co. →