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Does MI Paste/MI Paste PLUS have FDA 510K Clearance?

April 26, 2017clearance fda mi paste Plus

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Does MI Paste/MI Paste PLUS have FDA 510K Clearance?

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MI Paste received FDA 510K Clearance to sell and market MI Paste on October 20, 2004 (KO42200). MI Paste PLUS received FDA 510K Clearance on April 12 2007 (KO70854). Both MI Paste and MI Paste PLUS have FDA 510K Clearance as a prophy paste and for treating hypersensitivity. MI Paste is cleared in Canada by Health Canada, MI Paste PLUS is pending. Recommended Indications: To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, MI Paste/MI Paste PLUS can be used for the management of tooth sensitivity, post scaling, root planing and bleaching. Note the FDA does not give approvals but clearance based on the data submitted.