| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
055
|
Date of Entry 12/21/2020
|
|
FR Recognition Number
|
4-264
|
| Standard | |
ISO 9333 Second edition 2006-07
Dentistry - Brazing materials |
|
Identical AdoptionANSI ADA Standard No. 88-2019
Dental Brazing Alloys |
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Scope/Abstract| ADA 88-2019 specifies requirements and test methods for brazing filler alloys suitable for use in brazing cast dental restorations. |
|
| 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| FDA recognition of ISO 9333 Second edition 2006-07 [Rec# 4-264] will be superseded by recognition of ISO 9333 Third edition 2022-08 [Rec# 4-303]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-264] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-264] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3060 |
Alloy, Other Noble Metal
|
Class 2
|
EJS
|
| §872.3060 |
Alloy, Gold-Based Noble Metal
|
Class 2
|
EJT
|
| §872.3710 |
Alloy, Metal, Base
|
Class 2
|
EJH
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Noble Metal Alloys, issued August 2004.
2. Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Base Metal Alloys, issued August 2004.
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
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
