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  • 1.  Dental Zirconia Disc - Finished Device or Component

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2019 12:15
    This message was posted by a user wishing to remain anonymous

    Hi,

    Would a packaged and labeled Zirconia disc (Class II) be considered a finished device or a component according to the FDA?

    My initial thought is component since it does not appear to fit the criteria for a finished device. 

    The disc is used by a third party to produce custom dental devices for the patient.  

    Thanks


  • 2.  RE: Dental Zirconia Disc - Finished Device or Component

    Posted 24-Apr-2019 10:21
    Dear Anonymous,

    They are Class II devices in the US. Submitted 510(k)s for dental materials, including blanks.  Look up 3M Deutschland Zirconia blanks and things like Lava Ultimate (3M ESPE) in the FDA 510(k) database.   Manufacturers of the materials are the ones that file these, not the dental labs, which are exempt/under FDA discretion. Labs must follow GMPs in final finishing and keep traceability, but they manufacture to a specific patient order from the dentists.

    PM me if you need assistance with this.

    Good luck!


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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 3.  RE: Dental Zirconia Disc - Finished Device or Component

    Posted 24-Apr-2019 10:32
    These are the funny devices in the word of medical devices that while it is a component for further processing, it is considered a finished medical device.  Ginger makes some good references to examples of dental blank material that are regulated by the FDA that end up being a finished medical device.  Because the finished medical device is often patient specific and "manufactured" by the labs, the materials are actually regulated.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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