BEUDAMED
    Product Code: ECC FDA class 3 21 CFR 872.6730

    Sterilizer, Glass Bead

    Dental

    The Glass Bead Sterilizer is a dental device that uses a bath of heated glass beads to sterilize small metal dental instruments through dry heat conduction. It is classified as FDA Class 3, the highest risk category, reflecting concerns about sterility assurance and the potential for cross-contamination; marketing requires Premarket Approval (PMA). The product code is ECC and the applicable regulation is 21 CFR 872.6730, under the Dental medical specialty. Note: FDA issued a call for PMA submissions for this device class effective April 21, 1997.

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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
    ECC
    Device Class
    FDA class 3
    Regulation Number
    872.6730
    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

    Definition

    Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97