• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 4-221
ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
Scope/Abstract
This part of ISO 7494 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 part of ISO 7494 also specifies requirements for instructions for use and technical description.

This part of ISO 7494 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 International Standard.

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
§872.6640 Unit, Operative Dental Class 1 EIA
FDA Technical Contact
 Sheena Green
  FDA/OC/CDRH/OPEQ/OCEA/DCEAI/
  301-796-6279
  sheena.green@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.
-
-