BEUDAMED
    Product Code: EIG FDA class 1 21 CFR 872.4565

    Retractor, All Types

    Dental

    The Dental Retractor (All Types) encompasses a range of instruments including cheek, lip, and tongue retractors used to displace and hold soft tissues away from the operative site, improving clinician visibility and access during intraoral procedures. These devices are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIG, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    8
    FEI Numbers
    324
    Registration Numbers
    324
    Unique Applicants
    7
    Years Active
    21

    Basic Information

    Product Code
    EIG
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K971284 OPALDAM
    K854711 FIBRELIGHT ILLUMINATING ORAL RETRACTORS
    K832366 ZOLLER BURNED LIP CONFORMER
    K821784 BEACH GINGIVAL RETRACTION INSTR. TYPE B
    K771973 GINGITRACT
    K771399 LIP & CHEEK RETRACTOR
    K761024 RACESTYPTINE RINGS
    K760657 RACESTYPTINE CORD

    FEI Numbers

    This FDA classification entry is associated with 324 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 324 registration numbers. Click on an entry to view related FDA registrations.