| ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-153 |
| 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 part of ISO 9917 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. This part of ISO 9917 is applicable to both hand-mixed and capsulated cements for mechanical mixing. This part of ISO 9917 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. This part of ISO 9917 is not intended to address resin-modified water-based cements.
| 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 |