| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
4-340
|
| Standard | |
ANSI ADA Standard No. 46-2016
Dental Patient Chair |
|
Scope/Abstract| This standard is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. This standard specifies requirements, test methods, manufacturer's information, marking and packaging. |
|
| 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. |
|
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
|
| §872.6250 |
Chair, Dental, Without Operative Unit
|
Class 1
|
NRU
|
|
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
|
| Standards Development Organizations
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
