Recognized standard
9917-1 Second edition 2007-10-01
FDA recognition 4-153 · ISO · Dental/ENT
Key facts
| Recognition number | 4-153 |
|---|---|
| Designation | 9917-1 Second edition 2007-10-01 |
| Title | Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: