Recognized standard
Standard No. 197-2021
FDA recognition 4-375 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-375 |
|---|---|
| Designation | Standard No. 197-2021 |
| Title | Spoons and Bone Curettes in Dentistry |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | This specification 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. This standard is a modified adoption of… |
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: