BEUDAMED
    Product Code: EGY FDA class 2 21 CFR 892.1900

    Processor, Radiographic-Film, Automatic, Dental

    Radiology

    The Automatic Dental Radiographic-Film Processor is a device designed to automatically develop, fix, wash, and dry dental X-ray films through a series of chemical baths, replacing manual darkroom processing to improve throughput and consistency. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EGY, regulated under 21 CFR 892.1900 in the Radiology (RA) specialty.

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    510(k)s
    9
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    9
    Years Active
    22

    Basic Information

    Product Code
    EGY
    Device Class
    FDA class 2
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Review Panel
    RA
    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 9 510(k) clearances via K numbers.

    K Number Device Name
    K992896 DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
    K955825 SMITH S-100 TIME & TEMPERATURE CONTROL
    K955643 ALARA IMAGING SYSTEM
    K945682 PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
    K900156 AP201 DENTAL X-RAY FILM PROCESSOR
    K874118 MODEL 410 DENTAL X-RAY FILM PROCESSORS
    K811211 YOSHIDA AP 100
    K771433 AUTO. DEVEL. UNIT FOO DENTAL X-RAY
    K770783 FILM PROCESSOR, AUTOMATIC

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.