Recognized standard
20127 First edition 2005-03-15 Standard No.120-2009 (R2014)
FDA recognition 4-238 · ISO · Dental/ENT
Key facts
| Recognition number | 4-238 |
|---|---|
| Designation | 20127 First edition 2005-03-15 Standard No.120-2009 (R2014) |
| Title | Dentistry - Powered toothbrushes - General requirements and test methods Powered Toothbrushes |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Aug 21, 2017 |
| 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: