| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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049
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Date of Entry 06/07/2018
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|
FR Recognition Number
|
4-241
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| Standard | |
ISO 7491 Second edition 2000-09-01
Dental materials - Determination of colour stability |
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U.S. Identical AdoptionANSI ADA Standard No. 80-2001 (R2020)
Dental Materials-Determination of Color Stability |
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Scope/Abstract| This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water. |
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| 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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3690 |
Material, Tooth Shade, Resin |
Class 2 |
EBF |
| §872.3760 |
Resin, Denture, Relining, Repairing, Rebasing |
Class 2 |
EBI |
| §872.3770 |
Crown And Bridge, Temporary, Resin |
Class 2 |
EBG |
| §872.3900 |
Teeth, Artificial, Posterior With Metal Insert |
Class 1 |
ELJ |
| §872.3910 |
Teeth, Artificial, Backing And Facing |
Class 1 |
ELK |
| §872.3920 |
Teeth, Porcelain |
Class 2 |
ELL |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, Issued October 2005.
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 Contact
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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. |
