| ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability |
| Recognition Number | Dental/ENT |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 4-241 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3920 | Teeth, Porcelain | Class 2 | ELL |
| §872.3910 | Teeth, Artificial, Backing And Facing | Class 1 | ELK |
| §872.3900 | Teeth, Artificial, Posterior With Metal Insert | Class 1 | ELJ |
| §872.3770 | Crown And Bridge, Temporary, Resin | Class 2 | EBG |
| §872.3760 | Resin, Denture, Relining, Repairing, Rebasing | Class 2 | EBI |
| §872.3690 | Material, Tooth Shade, Resin | Class 2 | EBF |
| Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, Issued October 2005. |