Recognized standard
10637 Second edition 2018-05 Standard No. 177-2020
FDA recognition 4-305 · ISO · Dental/ENT
Key facts
| Recognition number | 4-305 |
|---|---|
| Designation | 10637 Second edition 2018-05 Standard No. 177-2020 |
| Title | Dentistry - Central suction source equipment Central Suction Source Equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies requirements and test methods for stationary, electrically powered central suction source equipment, including centrally located amalgam separators and air water separators. It also specifies requirements for information to be supplied by the manufacturer on the performance… |
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: