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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 4-287
ANSI ADA  Standard No. 116-2020
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
This standard defines physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer's instructions for use, marking and/or labeling requirements. This standard is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription. This standard is not applicable to oral rinses available by prescription only. This standard is a modified adoption of ISO 16408:2015, Dentistry - Oral hygiene products - Oral rinses.
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
§872.5580 Rinse, Oral, Antibacterial (By Physical Means) Class 2 NTO
N/A Saliva, Artificial LFD
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance for Industry and FDA Staff: Oral Rinse to Reduce the Adhesion of Dental Plaque, Issued September 2005.

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
 Bobak Shirmohammadi
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.