Recognized standard
11499 Third edition 2014-06 Standard No. 190-2020
FDA recognition 4-335 · ISO · Dental/ENT
Key facts
| Recognition number | 4-335 |
|---|---|
| Designation | 11499 Third edition 2014-06 Standard No. 190-2020 |
| Title | Dentistry - Single-use cartridges for local anaesthetics Single-Use Dental Cartridges for Local Anesthetics |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 11499:2014 gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics. ISO 11499:2014 specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall… |
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: