BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LIP & CHEEK RETRACTOR

    K Number: K771399 · Decision Aug 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    7
    Applicant Total
    20
    Review Days
    28

    Basic Information

    Device Name
    LIP & CHEEK RETRACTOR
    K Number
    K771399
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    L.D. CAULK CO.
    Date Received
    July 29, 1977
    Decision Date
    August 26, 1977
    Product Code
    EIG
    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
    EIG Retractor, All Types

    Similar 510(k) Clearances

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

    OPALDAM

    FDA 510(k)
    FDA Class 1 ·Dental

    FIBRELIGHT ILLUMINATING ORAL RETRACTORS

    FDA 510(k)
    FDA Class 1 ·Dental

    ZOLLER BURNED LIP CONFORMER

    FDA 510(k)
    FDA Class 1 ·Dental

    BEACH GINGIVAL RETRACTION INSTR. TYPE B

    FDA 510(k)
    FDA Class 1 ·Dental

    GINGITRACT

    FDA 510(k)
    FDA Class 1 ·Dental

    RACESTYPTINE RINGS

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

    Other Clearances by L.D. CAULK CO.

    K Number Device Name
    K802262 COMPOSITE RESTORATIVE
    K801690 VALIANT
    K790585 FINESSE
    K790586 CHEMBOND
    K780560 DENTAL AMALGAMATOR
    K780384 IMPROVED DYCAL
    K780301 CAULK TYLOK
    K771398 SHELL VENEER
    K771402 NUVA-COTE (MODIFICATION TO)
    K771400 IMPREGNATED DENTAL FLOSS
    Search all 20 clearances from L.D. CAULK CO. →