Recognized standard
28399 Third edition 2021-03 Standard No. 136-2022
FDA recognition 4-331 · ISO · Dental/ENT
Key facts
| Recognition number | 4-331 |
|---|---|
| Designation | 28399 Third edition 2021-03 Standard No. 136-2022 |
| Title | Dentistry - External tooth bleaching products Dentistry - External Tooth Bleaching Products |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth… |
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: