Recognized standard
Standard No. 159-2024
FDA recognition 4-359 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-359 |
|---|---|
| Designation | Standard No. 159-2024 |
| Title | Dentistry - Coiled Springs for Use in Orthodontics |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard applies to coiled springs for use in orthodontic appliances. This standard gives details of methods to compare the physical and mechanical behavior of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements. This is a modified… |
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: