| ISO 4823 Fourth edition 2015-08-01 Dentistry - Elastometric impression materials |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-225 |
| 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.
This International Standard specifies the requirements and tests that the state-of-the art body of knowledge suggests for helping determine whether the elastomeric impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3660 | Material, Impression | Class 2 | ELW |
| Guidance for Industry and FDA Staff Dental Impression Materials - Premarket Notification Document issued on: August 17, 1998 |