Recognized standard
8325 Second edition 2004-09-15
FDA recognition 4-244 · ISO · Dental/ENT
Key facts
| Recognition number | 4-244 |
|---|---|
| Designation | 8325 Second edition 2004-09-15 |
| Title | Dentistry - Test methods for rotary instruments |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This International Standard specifies methods for measuring the dimensional characteristics, neck strength and surface roughness of dental rotary instruments, such as burs, cutters, polishers, diamond and abrasive instruments. This International Standard does not provide test methods for the… |
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: