BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    PSP TEMP - TRAY

    K Number: K853093 · Decision Sep 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    45

    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
    PSP TEMP - TRAY
    K Number
    K853093
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3670
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Psp Dental Co., Ltd.
    Date Received
    July 23, 1985
    Decision Date
    September 6, 1985
    Product Code
    EBH
    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
    EBH Material, Impression Tray, Resin

    Similar 510(k) Clearances

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

    PERMAGEN UNIVERSAL BONDING RESIN

    FDA 510(k)
    FDA Class 1 ·Dental

    PALATRAY LC MINT

    FDA 510(k)
    FDA Class 1 ·Dental

    LC TRAY MATERIAL

    FDA 510(k)
    FDA Class 1 ·Dental

    PALADISC LC

    FDA 510(k)
    FDA Class 1 ·Dental

    POLYESTER RESIN HAND MOLDED TRAY

    FDA 510(k)
    FDA Class 1 ·Dental

    PALAVIT L

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Psp Dental Co., Ltd.

    K Number Device Name
    K853089 SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
    K853094 EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
    K853092 PSP C & B TEMP
    K853091 CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
    K853090 CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO