| ISO 10477 Second edition 2004-10-01 Dentistry - Polymer-based crown and bridge materials |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-126 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Andrew Steen FDA/OMPT/CDRH/ODE/DAGID/DEDB/ 301-796-6284 andrew.steen@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.
ISO 10477:2004 classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements.
ISO 10477:2004 is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.
ISO 10477:2004 is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3770 | Crown And Bridge, Temporary, Resin | Class 2 | EBG |
| §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 26, 2005. |