Recognized standard
18556 Frist edition 2016-04
FDA recognition 4-289 · ISO · Dental/ENT
Key facts
| Recognition number | 4-289 |
|---|---|
| Designation | 18556 Frist edition 2016-04 |
| Title | Dentistry - Intraoral spatulas |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items. NOTE This includes instruments used for placement and contouring of non-metallic… |
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: