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

    ALPHA-DENT COMPOSITE SURFACE SEALANT

    K Number: K960165 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    32
    Review Days
    59

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ALPHA-DENT COMPOSITE SURFACE SEALANT
    K Number
    K960165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wallace A. Erickson & Co.
    Date Received
    January 16, 1996
    Decision Date
    March 15, 1996
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.

    SRGC-06

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

    FDA 510(k)
    FDA Class 2 ·Dental

    Dual Core

    FDA 510(k)
    FDA Class 2 ·Dental

    Dura-Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    Grandio disc multicolor

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    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)
    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
    K935625 ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
    Search all 32 clearances from Wallace A. Erickson & Co. →