From 31 October 2012, all tooth whitening products are permitted to contain from 0.1% to 6% hydrogen peroxide and the supply of these products is restricted to registered dental professionals only. SDI's Pola Day 3% and 6% hydrogen peroxide and Pola Night 10% and 16% carbamide peroxide comply with the new whitening regulation and are now available.
SDI has successfully gained approval for the range of Pola products which contain greater than 6% hydrogen peroxide as medical devices under a revised product classification. The packaging will comply with Medical Device Directive requirements based on modified 'Indications of Use' as follows: lightly etching away surface staining on vital teeth; lightly etching away surface staining on non-vital teeth; assisting in the brightening of discoloured teeth; and removal of surface stains on teeth discoloured by medications such as tetracycline, minocycline, fluorosis, food related stains and age dependent changes.
These products are: Pola Day 7.5% and 9.5% hydrogen peroxide, Pola Night 22% carbamide peroxide, Pola Day CP 35% carbamide peroxide, Pola Office 35% hydrogen peroxide and Pola Office Plus 37.5% hydrogen peroxide.
These higher percentages will enable dental practices to continue to offer very fast treatments.
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New products comply with whitening rules. Br Dent J 213, 577 (2012). https://doi.org/10.1038/sj.bdj.2012.1118
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DOI: https://doi.org/10.1038/sj.bdj.2012.1118