Recognized standard
21533 Second edition 2018-01 Standard No. 183-2020
FDA recognition 4-393 · ISO · Dental/ENT
Key facts
| Recognition number | 4-393 |
|---|---|
| Designation | 21533 Second edition 2018-01 Standard No. 183-2020 |
| Title | Dentistry - Reprocessable cartridge syringes for intraligamentary injections Reprocessable Cartridge Syringes for Intraligamentary Injections |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 21533:2018 specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections. ISO 21533:2018 specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is… |
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: