BEUDAMED
    Product Code: EMS FDA class 1 21 CFR 872.4565

    Curette, Periodontic

    Dental

    The periodontic curette is a dental instrument with a rounded tip used for subgingival scaling, root planing, and removal of soft tissue from periodontal pockets. It is classified as FDA Class 1, indicating minimal risk, and is subject only to general controls without a premarket submission requirement. The product code is EMS, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply.

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    510(k)s
    7
    FEI Numbers
    85
    Registration Numbers
    85
    Unique Applicants
    6
    Years Active
    12

    Basic Information

    Product Code
    EMS
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K931329 DENTAL INSTRUMENTS CURETTE PERIODONTAL
    K872091 CURRETTES, ALVEOLAR (MOLT AND MILLER)
    K870590 CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY
    K841011 ELEVATOR - VARIOUS
    K834072 INSTRUMENT, DENTAL
    K823319 DENTAL INSTRUMENTS - SCALERS
    K821789 BEACH CURETTE NO. 2 AND NO. 3 T.G.

    FEI Numbers

    This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.