Recognized standard
21606 First edition 2007-06 Standard No. 105-2010 (R2015)
FDA recognition 4-267 · ISO · Dental/ENT
Key facts
| Recognition number | 4-267 |
|---|---|
| Designation | 21606 First edition 2007-06 Standard No. 105-2010 (R2015) |
| Title | Dentistry - Elastomeric auxiliaries for use in orthodontics Orthodontic Elastomeric Materials |
| 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 21606:2007 is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances. |
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: