Recognized standard
17254 First edition 2016-07 [Including AMD1:2020]
FDA recognition 4-392 · ISO · Dental/ENT
Key facts
| Recognition number | 4-392 |
|---|---|
| Designation | 17254 First edition 2016-07 [Including AMD1:2020] |
| Title | Dentistry - Coiled springs for use in orthodontics [Including AMENDMENT 1 (2020)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements. |
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: