Recognized standard
13078-2 First edition 2016-07 Standard No. 164-2018 (R2023)
FDA recognition 4-382 · ISO · Dental/ENT
Key facts
| Recognition number | 4-382 |
|---|---|
| Designation | 13078-2 First edition 2016-07 Standard No. 164-2018 (R2023) |
| Title | Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze Dental Furnance, Part 2: Test Method for Evaluation of Furnace Program via Firing Glaze |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 13078-2:2016 determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic. The test method is suitable for powdered dental ceramics… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: