Recognized standard
20795-2 Second edition 2013-03-01
FDA recognition 4-233 · ISO · Dental/ENT
Key facts
| Recognition number | 4-233 |
|---|---|
| Designation | 20795-2 Second edition 2013-03-01 |
| Title | Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of ISO 20795 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further… |
At a glance
- 10–99 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: