| ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-181 |
| 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 requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting.
The polymer-based luting materials covered by this International Standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3690 | Material, Tooth Shade, Resin | Class 2 | EBF |
| Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions. Document issued on October 26, 2005 |