BEUDAMED
    Product Code: KCS FDA class 1 21 CFR 872.3730

    Pantograph

    Dental

    A dental pantograph is a precision jaw-movement recording instrument that traces and replicates the three-dimensional movements of the mandible relative to the maxilla, used to program dental articulators for the fabrication of complex prosthetic restorations or for diagnosis of temporomandibular disorders. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KCS is regulated under 21 CFR 872.3730 in the Dental medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Research product code KCS in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KCS
    Device Class
    FDA class 1
    Regulation Number
    872.3730
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    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.