| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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062
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Date of Entry 05/29/2024
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|
FR Recognition Number
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4-326
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| Standard | |
ISO 9687 Second edition 2015-02
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
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Scope/Abstract| ISO 9687:2015 specifies graphical symbols for dental equipment. It is intended that the symbols are to be used on the appropriate piece of dental equipment and in documents pertaining to dental equipment, for example in instructions for use, marking, labelling, and technical product documentation. |
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| 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.
Standard is recognized on a regulatory basis:
- Labeling
- Symbol |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR Part 660 Additional Standards For Diagnostic Substances for Laboratory Tests |
| 21 CFR Part 801 Labeling |
| 21 CFR Part 809 In Vitro Diagnostic Products for Human Use |
| 21 CFR Part 872 Dental Devices |
|
Relevant FDA Guidance and/or Supportive Publications*
Final Rule, Use of Symbols in Labeling, issued June 2016.
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. |
