BEUDAMED
    Product Code: EHZ FDA class 1 21 CFR 872.6640

    Evacuator, Oral Cavity

    Dental

    The Oral Cavity Evacuator is a dental device, such as a suction tip or saliva ejector, connected to a vacuum system to remove fluids, blood, saliva, and debris from the oral cavity during dental procedures, maintaining a clear working field. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHZ, regulated under 21 CFR 872.6640 in the Dental (DE) specialty.

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    510(k)s
    17
    FEI Numbers
    138
    Registration Numbers
    138
    Unique Applicants
    15
    Years Active
    21

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    Basic Information

    Product Code
    EHZ
    Device Class
    FDA class 1
    Regulation Number
    872.6640
    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 17 510(k) clearances via K numbers.

    K Number Device Name
    K973248 IMTEC BONE COLLECTOR SYSTEM
    K941164 TAP EXPRESS EJECTOR
    K911072 SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
    K903718 OROSCOPE MODEL NUMBER COS-100
    K892882 DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
    K892881 DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
    K880754 DRI-CLAVE LIQUID KLEENZALL
    K873545 PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT
    K874401 TITANIUM SUCTION TIP
    K864621 VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
    K863769 EVACUATOR TIPS
    K801682 SPACELINE HIGH VOLUME EVACUATION HANDPIE
    K782068 MVS UNIT, MODEL SEU-8 AND DEU-8, 80
    K781488 MVS-MODEL SEU-6, DEU-6
    K781486 STERI-VAC POWER UNITS
    K780701 DENTAL OFFICE ENVIRONMENT CONTROL UNIT
    K770152 AUTO-RINSE

    FEI Numbers

    This FDA classification entry is associated with 138 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 138 registration numbers. Click on an entry to view related FDA registrations.