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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 4-250
ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
Scope/Abstract
This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered.

This document also specifies requirements for the instructions for use, for the technical description, for marking and for packaging.

Operator's stools, portable dental equipment and operating lights are not in the scope of this document.

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.
Transition Period
FDA recognition of ISO 7494-1 Second edition 2011-08-15 [Rec# 4-213] will be superseded by recognition of ISO 7494-1 Third edition 2018-06 [Rec# 4-250]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-213] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 4-213] will not be accepted.
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 Contacts
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@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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