BEUDAMED
    Product Code: MMT FDA class 3 21 CFR 872.3820

    Resin, Root Canal Filling Containing Chloroform

    Dental

    The Root Canal Filling Resin Containing Chloroform is an endodontic material used to fill and seal the root canal system following pulp removal, with chloroform serving as a solvent component to plasticize gutta-percha for better adaptation, though concerns about chloroform's cytotoxicity contribute to its Class 3 regulatory status. Under 21 CFR 872.3820 in the Dental specialty, as a Class 3 device it requires Premarket Approval (PMA) due to the potential risks of chloroform-containing dental materials. It carries no implant or life-sustaining flags.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    MMT
    Device Class
    FDA class 3
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    2

    Device Characteristics

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