Recognized standard
27020 Second edition 2019-06 Standard No.100-2020
FDA recognition 4-313 · ISO · Dental/ENT
Key facts
| Recognition number | 4-313 |
|---|---|
| Designation | 27020 Second edition 2019-06 Standard No.100-2020 |
| Title | Dentistry - Brackets and tubes for use in orthodontics Orthodontic Brackets and Tubes |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This… |
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: