Recognized standard
15912 Second edition 2016-01
FDA recognition 4-390 · ISO · Dental/ENT
Key facts
| Recognition number | 4-390 |
|---|---|
| Designation | 15912 Second edition 2016-01 |
| Title | Dentistry - Refractory investment and die material |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 15912:2016 gives requirements and test methods for determining the compliance of dental casting investment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder… |
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: