Recognized standard
13078 First edition 2013-02 Standard No.163-2018
FDA recognition 4-381 · ISO · Dental/ENT
Key facts
| Recognition number | 4-381 |
|---|---|
| Designation | 13078 First edition 2013-02 Standard No.163-2018 |
| Title | Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 13078:2013 specifies a test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C. |
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: