BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PERTAC II/PERTAC II APLITIP

    K Number: K962440 · Decision Sep 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    17
    Review Days
    79

    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
    PERTAC II/PERTAC II APLITIP
    K Number
    K962440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Espe GmbH & Co. Kg.
    Date Received
    June 24, 1996
    Decision Date
    September 11, 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 Espe GmbH & Co. Kg.

    K Number Device Name
    K974231 POSITION PENTA, POSITION PENTA QUICK
    K973513 SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
    K973262 KETAC-FIL APLICAP PLUS
    K972892 CAVIT-LC
    K963735 COJET SYSTEM
    K963737 HYCEM APLICAP
    K962428 EBS (ESPE BONDING SYSTEM)
    K962442 HYTAC APLITIP/HYTAC OSB
    K960954 KETAC-MOLAR APLICAP
    K960547 DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
    Search all 17 clearances from Espe GmbH & Co. Kg. →