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ANSI/ADA 136-2015

ANSI/ADA Standard No. 136 Products for External Tooth Bleaching

This Standard specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and instructions for use. This Standard is not applicable to tooth bleaching products: ? specified in ISO 11609; ? those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; ? auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This Standard does not specify biological safety aspects of tooth bleaching products. NOTE A tooth bleaching product can be evaluated for its biological safety using ADA Standard No. 41, ISO 10993-1 and ISO 7405.


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American Dental Association [ada]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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