Recognized standard
Standard No. 46-2016
FDA recognition 4-340 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-340 |
|---|---|
| Designation | Standard No. 46-2016 |
| Title | Dental Patient Chair |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. This standard specifies requirements, test methods, manufacturer's information, marking and… |
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: