Recognized standard
28399 First edition 2011-01 Standard No. 136-2015 (R2020)
FDA recognition 4-291 · ISO · Dental/ENT
Key facts
| Recognition number | 4-291 |
|---|---|
| Designation | 28399 First edition 2011-01 Standard No. 136-2015 (R2020) |
| Title | Dentistry - Products for external tooth bleaching Products for External Tooth Bleaching |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 28399:2011 specifies 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: