Recognized standard
20126 Third edition 2022-03
FDA recognition 4-297 · ISO · Dental/ENT
Key facts
| Recognition number | 4-297 |
|---|---|
| Designation | 20126 Third edition 2022-03 |
| Title | Dentistry - Manual toothbrushes - General requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 19, 2022 |
| 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: