BEUDAMED
    Product Code: NUX FDA class 1 21 CFR 872.3520

    Cleanser, Denture, Prescription

    Dental

    The Prescription Denture Cleanser is an effervescent tablet intended for the removal of microorganisms from removable dentures and retainers, used to maintain oral hygiene and prosthesis hygiene. Unlike over-the-counter cleansers, this prescription formulation may contain more active antimicrobial components. It is an FDA Class 1 device regulated under 21 CFR 872.3520 in the Dental specialty, with product code NUX, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.

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    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NUX
    Device Class
    FDA class 1
    Regulation Number
    872.3520
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    Definition

    Effervescent tablet for the removal of micro-organisms from removable dentures and retainers.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.