Recognized standard
28888 First edition 2013-10 Standard No. 151-2015 (R2020)
FDA recognition 4-292 · ISO · Dental/ENT
Key facts
| Recognition number | 4-292 |
|---|---|
| Designation | 28888 First edition 2013-10 Standard No. 151-2015 (R2020) |
| Title | Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 28888:2013 specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models. |
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: