Recognized standard
20127 Third edition 2025-05
FDA recognition 4-353 · ISO · Dental/ENT
Key facts
| Recognition number | 4-353 |
|---|---|
| Designation | 20127 Third edition 2025-05 |
| Title | Dentistry - Physical properties of powered toothbrushes |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use. There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this… |
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: