Recognized standard
27020 First edition 2010-12-15 Standard No.100-2012
FDA recognition 4-218 · ISO · Dental/ENT
Key facts
| Recognition number | 4-218 |
|---|---|
| Designation | 27020 First edition 2010-12-15 Standard No.100-2012 |
| 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 | Jan 27, 2015 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances. This International Standard gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging… |
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: