BEUDAMED
    Product Code: EJP FDA class 1 21 CFR 872.3150

    Articulators

    Dental

    Dental Articulators are mechanical devices used in dental laboratories to simulate jaw movement by holding dental casts of the upper and lower arches in their correct spatial relationship, allowing technicians to fabricate prostheses that will function accurately in the patient's mouth. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJP, regulated under 21 CFR 872.3150 in the Dental (DE) specialty. This device is exempt from GMP requirements.

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    510(k)s
    11
    FEI Numbers
    95
    Registration Numbers
    95
    Unique Applicants
    10
    Years Active
    14

    Basic Information

    Product Code
    EJP
    Device Class
    FDA class 1
    Regulation Number
    872.3150
    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 11 510(k) clearances via K numbers.

    K Number Device Name
    K926190 ALRAND INC. (DENTAL HAND INSTRUMENTS)
    K896131 GNATHOMAT ARTICULATOR
    K892373 DENTAL PLASTIC BITE FORK
    K884418 PREMIER DIE-TRAK ARTICULATOR
    K872943 DISPOSABLE ARTICULATOR
    K863009 GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
    K854702 PLASTIC MOUNTING RINGS
    K833039 HANDY IIM
    K811075 BALANCE ARTICULATOR
    K810971 THE GNATOMET
    K801342 DISPOSABLE ARTICULATOR

    FEI Numbers

    This FDA classification entry is associated with 95 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 95 registration numbers. Click on an entry to view related FDA registrations.