Recognized standard
11143 Second edition 2008-07 Standard No. 108-2009, Addendum (R2022)
FDA recognition 4-334 · ISO · Dental/ENT
Key facts
| Recognition number | 4-334 |
|---|---|
| Designation | 11143 Second edition 2008-07 Standard No. 108-2009, Addendum (R2022) |
| Title | Dentistry - Amalgam separators Amalgam Separators |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 11143:2008 specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure… |
At a glance
- None 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: