| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
066
|
Date of Entry 05/25/2026
|
|
FR Recognition Number
|
4-368
|
| Standard | |
ISO 4823 Sixth edition 2025-06
Dentistry - Elastomeric impression and bite registration materials |
|
Scope/Abstract| This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. |
|
| 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. |
|
Transition Period
| FDA recognition of ISO 4823 Fifth edition 2021-02 [Rec# 4-278] will be superseded by recognition of ISO 4823 Sixth edition 2025-06 [Rec# 4-368]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-278] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 4-278] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3660 |
Material, Impression
|
Class 2
|
ELW
|
|
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 Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
