Recognized standard
Standard No. 54-1986 (R2024)
FDA recognition 4-357 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-357 |
|---|---|
| Designation | Standard No. 54-1986 (R2024) |
| Title | Double-Pointed, Parenteral, Single Use Needles for Dentistry |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard covers sterile, single-use, individually-packaged, double-pointed needles with a means of secure attachment to cartridge-type syringes used for dental, regional, anesthetic injections. |
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: