Recognized standard
Standard No. 34-2025
FDA recognition 4-349 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-349 |
|---|---|
| Designation | Standard No. 34-2025 |
| Title | Dental Cartridge Syringes |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This is a modified adoption of ISO 9997 Third edition 2020-01 Dentistry-Cartridge syringes. |
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: