Recognized standard
3964 Third edition 11-2016
FDA recognition 4-269 · ISO · Dental/ENT
Key facts
| Recognition number | 4-269 |
|---|---|
| Designation | 3964 Third edition 11-2016 |
| Title | Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 3964:2016 specifies the coupling between handpieces and motors connected to dental units. ISO 3964:2016 specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation… |
At a glance
- 1–9 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: