Recognized standard
20749 First edition 2017-03 Standard No. 144-2018
FDA recognition 4-246 · ISO · Dental/ENT
Key facts
| Recognition number | 4-246 |
|---|---|
| Designation | 20749 First edition 2017-03 Standard No. 144-2018 |
| Title | Dentistry - Pre-capsulated dental amalgam Alloy for Dental Amalgam |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration. This document specifies the requirements and test… |
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: