Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021

FR Recognition Number

4-287

Standard

ANSI ADA Standard No. 116-2020
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)

Scope/Abstract

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

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 Organizations