| ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-188 |
| 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.
ISO 9917‑2:2010 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3275 | Cement, Dental | Class 2 | EMA |
| Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document issued on: August 18, 1998 |