Recognized standard
7494-1 Third edition 2018-06
FDA recognition 4-250 · ISO · Dental/ENT
Key facts
| Recognition number | 4-250 |
|---|---|
| Designation | 7494-1 Third edition 2018-06 |
| Title | Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| 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
- 1–9 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: