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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 4-292
Standard
ISO  28888 First edition 2013-10
Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
Identical Adoption
ANSI ADA Standard No. 151-2015 (R2020)
Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
Scope/Abstract
ISO 28888:2013 specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models.
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 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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