Recognized standard
9917-2 Second edition 2010-04-15
FDA recognition 4-188 · ISO · Dental/ENT
Key facts
| Recognition number | 4-188 |
|---|---|
| Designation | 9917-2 Second edition 2010-04-15 |
| Title | Dentistry - Water-based cements - Part 2: Resin-modified cements |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: