Recognized standard
28158 Second edition 2018-09 Standard No. 185-2020
FDA recognition 4-290 · ISO · Dental/ENT
Key facts
| Recognition number | 4-290 |
|---|---|
| Designation | 28158 Second edition 2018-09 Standard No. 185-2020 |
| Title | Dentistry - Integrated dental floss and handles Integrated Dental Floss and Handles |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment. This document is applicable to integrated dental floss and handles for manual use. It does not include… |
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: