Recognized standard
Standard No. 34-2013
FDA recognition 4-271 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-271 |
|---|---|
| Designation | Standard No. 34-2013 |
| Title | Dental Cartridge Syringes |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements and test methods for dental cartridge syringes which are reusable dental syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anesthetics. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: