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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 064 Date of Entry 05/26/2025 
FR Recognition Number 4-342
Standard
ANSI ADA  Standard No. 47-2-2021
Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
Scope/Abstract
This document specifies requirements and test methods concerning:

a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.

This document also specifies requirements for instructions for use and technical description. This document is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.

This standard is a modified adoption of ISO 7494-2:2015.
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
§872.6250 Chair, Dental, With Operative Unit Class 1 KLC
§872.6640 Unit, Suction Operatory Class 1 EBR
§872.6640 Unit, Operative Dental Class 1 EIA
§872.6640 Unit, Operative Dental, Accessories Class 1 NRD
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
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  Lauren.Giles@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
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)
Dental/ENT
*These are provided as examples and others may be applicable.
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