BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RANIR PLAX RX

    K Number: K935906 · Decision Sep 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    357
    Registration Numbers
    357
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    RANIR PLAX RX
    K Number
    K935906
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ranir/Dcp Corp.
    Date Received
    December 10, 1993
    Decision Date
    September 2, 1994
    Product Code
    EAX
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EAX Mirror, Mouth

    Similar 510(k) Clearances

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    ORALVUE DENTAL MIRROR

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    RETRO MIRROR

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    NIL

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    DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY

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    GLASS MOUTH MIRRORS, REUSABLE

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    FOGCUTTER DENTAL MOUTH MIRROR

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    FDA Class 1 ·Dental
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    Other Clearances by Ranir/Dcp Corp.

    K Number Device Name
    K955530 RANIR HI-TECHNOLOGY DENTAL FLOSS
    K942690 RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE
    K942689 RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE
    K935522 RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE
    K924739 THE DENTIST'S TOOTH POLISHER