Recognized standard
16409 Second edition 2016-10 Standard No. 125-2018
FDA recognition 4-283 · ISO · Dental/ENT
Key facts
| Recognition number | 4-283 |
|---|---|
| Designation | 16409 Second edition 2016-10 Standard No. 125-2018 |
| Title | Dentistry - Oral care products - Manual interdental brushes Manual Interdental Brushes |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 16409:2016 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer's instructions for… |
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: