Recognized standard
8325 Third edition 2023-03
FDA recognition 4-317 · ISO · Dental/ENT
Key facts
| Recognition number | 4-317 |
|---|---|
| Designation | 8325 Third edition 2023-03 |
| Title | Dentistry - Test methods for rotary instruments |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments… |
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: