Recognized standard
Standard No. 116-2020
FDA recognition 4-287 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-287 |
|---|---|
| Designation | Standard No. 116-2020 |
| Title | Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard defines physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer's instructions for use, marking and/or labeling requirements. This standard is not applicable to other delivery systems (e.g. mouthsprays… |
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: