Recognized standard
Standard No. 63-2020
FDA recognition 4-330 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-330 |
|---|---|
| Designation | Standard No. 63-2020 |
| Title | Endodontic Instruments - Auxillary |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited in ANSI/ADA Standard Nos. 28, 71, 95 or 101. It also specifies requirements for size, product designation, safety considerations, instructions and… |
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: