BEUDAMED
    Product Code: EMB FDA class 1 21 CFR 872.3275

    Zinc Oxide Eugenol

    Dental

    Zinc Oxide Eugenol (ZOE) is a dental material composed of zinc oxide powder and eugenol liquid that, when mixed, forms a paste used as a temporary cement, sedative base, pulp capping agent, or impression material due to its obtundent and antimicrobial properties. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMB, regulated under 21 CFR 872.3275 in the Dental (DE) specialty.

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    510(k)s
    11
    FEI Numbers
    67
    Registration Numbers
    67
    Unique Applicants
    11
    Years Active
    39

    Basic Information

    Product Code
    EMB
    Device Class
    FDA class 1
    Regulation Number
    872.3275
    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
    K161630 Provicol QM Plus
    K120695 DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
    K110759 TEMPOCEM
    K073539 PROVISA CEM
    K020158 NON-EUGENOL TEMPORARY CEMENT
    K941066 DENTAL 911
    K861681 DENTIMEDIC DENTAL EMERGENCY KIT
    K862745 EUGENOL USP
    K821581 DEN TEMP
    K801779 OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT
    K772315 KWIKAP

    FEI Numbers

    This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.