| ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-198 |
| 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 non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
This International Standard also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3275 | Zinc Oxide Eugenol | Class 1 | EMB |
| Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification Document, Issued August 1998. |