BEUDAMED
    Product Code: EHP FDA class 1 21 CFR 872.3285

    Clasp, Preformed

    Dental

    The Preformed Clasp is a prefabricated metal retentive component used in removable partial denture frameworks to engage undercuts on abutment teeth and provide retention for the prosthesis. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHP, regulated under 21 CFR 872.3285 in the Dental (DE) specialty.

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    510(k)s
    8
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    7
    Years Active
    22

    Basic Information

    Product Code
    EHP
    Device Class
    FDA class 1
    Regulation Number
    872.3285
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K022032 ACETAL
    K983558 ACETAL DENTAL/PREFORMED CLASP
    K974622 DENTAL D
    K955946 ACETAL DENTAL/PREFORMED CLASP
    K954971 ACETAL DENTAL/PREFORMED CLASP
    K854765 INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
    K800575 VACUDENT LUMIX 70
    K800574 VACUDENT LUMIX 65

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.