| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
063
|
Date of Entry 12/23/2024
|
|
FR Recognition Number
|
4-329
|
| Standard | |
ISO 6872 Fifth edition 2024-08
Dentistry - Ceramic materials |
|
Scope/Abstract| This document specifies the requirements, recommendations and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses. |
|
| 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| FDA recognition of ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] [Rec# 4-251] will be superseded by recognition of ISO 6872 Fifth edition 2024-08 [Rec# 4-329]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-251] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 4-251] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3920 |
Teeth, Porcelain
|
Class 2
|
ELL
|
| §872.6660 |
Powder, Porcelain
|
Class 2
|
EIH
|
|
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. |
