Recognized standard
Standard No. 119-2021
FDA recognition 4-293 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-293 |
|---|---|
| Designation | Standard No. 119-2021 |
| Title | Manual Toothbrushes |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 30, 2022 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard describes requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. Also specified is a test method for determining the resistance of the tufted portion of manual toothbrushes to deflection… |
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: