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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 4-291
Standard
ISO  28399 First edition 2011-01
Dentistry - Products for external tooth bleaching
Identical Adoption
ANSI ADA Standard No. 136-2015 (R2020)
Products for External Tooth Bleaching
Scope/Abstract
ISO 28399:2011 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). It also specifies requirements for their packaging, labelling and instructions for use.

The following tooth bleaching products are not covered by ISO 28399:2011:
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.6475 Heat Source For Bleaching Teeth Class 1 EEG
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  Michael.Adjodha@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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