Recognized standard
Standard No. 47-1-2021
FDA recognition 4-341 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-341 |
|---|---|
| Designation | Standard No. 47-1-2021 |
| Title | Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered. This document also specifies requirements for the instructions for use, for the technical description, for… |
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: