Recognized standard
6873 Third edition 2013-04 Standards No. 25-2015 (R2021)
FDA recognition 4-365 · ISO · Dental/ENT
Key facts
| Recognition number | 4-365 |
|---|---|
| Designation | 6873 Third edition 2013-04 Standards No. 25-2015 (R2021) |
| Title | Dentistry - Gypsum products Dental Gypsum Products |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 6873:2013 gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, moulds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It… |
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: