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Classification of plaque disclosing tablets

  • 1.  Classification of plaque disclosing tablets

    Posted 13-Jun-2012 11:12
    I am hoping that someone can help me with the classification of plaque disclosing tablets in the US. These are the red or blue tablets one usually gets as a kid that you chew after brushing your teeth to see what plaque you missed.

    I am getting the runaround from FDA, i.e. no firm answer. I cannot find a medical device product code, regulation, or 510(k)s. These tablets are made of vegetable dyes, and I don't think plaque is considered a disease.

    Can anyone help me with this?

    Thanks,
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    Paula Bojsen
    Grand Rapids, MI
    United States
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