| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
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Date of Entry 05/29/2023
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|
FR Recognition Number
|
4-303
|
| Standard | |
ISO 9333 Third edition 2022-08
Dentistry - Brazing materials |
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Scope/AbstractThis document specifies the requirements and test methods for dental brazing materials suitable for use in metallic restorations.
Brazing materials with silver as the main component are excluded from this document.
|
|
| Extent of Recognition
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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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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| FDA recognition of ISO 9333 Second edition 2006-07 [Rec# 4-264] will be superseded by recognition of ISO 9333 Third edition 2022-08 [Rec# 4-303].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. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
