| 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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4-327
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| Standard | |
ISO 21531 First edition 2009-02
Dentistry - Graphical symbols for dental instruments |
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Scope/Abstract| ISO 21531:2009 presents a series of graphical symbols for dental instruments. They are set out particularly for this area of dentistry or corresponding specific areas within dentistry. General symbols are taken from relevant ISO, IEC or other international documents. Several new symbols presented by manufacturers or users have been added. |
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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 |
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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 |
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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. |
