Recognized standard
Standard No. 119-2023
FDA recognition 4-339 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-339 |
|---|---|
| Designation | Standard No. 119-2023 |
| Title | Dentistry-Manual Toothbrushes |
| 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 the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all… |
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: