SS-EN-ISO-28399 › Dentistry - External tooth bleaching products (ISO 28399:2021)
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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 manufacturers 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 countrys regulatory body.
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Designation Name
SS-EN ISO 28399:2021
Revision Level
2021 EDITION
Status
Current
Publication Date
April 12, 2021
Language(s)
English
Page Count
32
International Equivalent
EN ISO 28399:2021(IDT); ISO 28399:2021(IDT)