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ISO 28399:2021

Dentistry — External tooth bleaching products

Standard Details

This document specifies the 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 manufacturer's instructions for use.

This document is not applicable to tooth bleaching products:

— specified in ISO 11609;

— 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 document does not specify biological safety aspects of tooth bleaching products.

NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.

General Information

Status : Published
Standard Type: Main
Document No: ISO 28399:2021
Document Year: 2021
Pages: 22
Edition: 3
  • ICS:
  • 97.170 Body care equipment

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ISO 28399:2021
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