| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
049
|
Date of Entry 06/07/2018
|
|
FR Recognition Number
|
4-241
|
| Standard | |
ISO 7491 Second edition 2000-09-01
Dental materials - Determination of colour stability |
|
Identical AdoptionANSI ADA Standard No. 80-2001 (R2020)
Dental Materials-Determination of Color Stability |
|
Scope/Abstract| This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water. |
|
| 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. |
|
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
|
Denture relining, repairing, or rebasing resin. 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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
