| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
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Date of Entry 05/26/2025
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|
FR Recognition Number
|
4-341
|
| Standard | |
ANSI ADA Standard No. 47-1-2021
Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
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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. This standard is a modified adoption of ISO 7494-1:2018. |
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| Extent of Recognition
|
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. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
