Recognized standard
15841 Second edition 2014-08 Standard No. 32-2017
FDA recognition 4-268 · ISO · Dental/ENT
Key facts
| Recognition number | 4-268 |
|---|---|
| Designation | 15841 Second edition 2014-08 Standard No. 32-2017 |
| Title | Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] Orthodontic Wires |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | ISO 15841:2014 specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. ISO 15841:2014 gives detailed requirements concerning the presentation of the… |
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: