Recognized standard
19023 First edition 2018-02 Standard No. 178-2019
FDA recognition 4-266 · ISO · Dental/ENT
Key facts
| Recognition number | 4-266 |
|---|---|
| Designation | 19023 First edition 2018-02 Standard No. 178-2019 |
| Title | Dentistry - Orthodontic anchor screws Orthodontic Anchor Screws |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information… |
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: