| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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4-335
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| Standard | |
ISO 11499 Third edition 2014-06
Dentistry - Single-use cartridges for local anaesthetics |
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Identical AdoptionANSI ADA Standard No. 190-2020
Single-Use Dental Cartridges for Local Anesthetics |
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Scope/AbstractISO 11499:2014 gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.
ISO 11499:2014 specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes. Labelling requirements are also specified.
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.6770 |
Syringe, Cartridge
|
Class 2
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EJI
|
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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. |
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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. |
