Recognized standard
7488 Second edition 2018-04 Standard No. 43-2020
FDA recognition 4-288 · ISO · Dental/ENT
Key facts
| Recognition number | 4-288 |
|---|---|
| Designation | 7488 Second edition 2018-04 Standard No. 43-2020 |
| Title | Dentistry - Mixing machines for dental amalgam Electrically Powered Dental Amalgamators |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam. ISO 7488:2018 specifies the test methods used to determine conformity with these requirements. ISO 7488:2018 refers to those… |
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: