Recognized standard
Standard No. 63-2013
FDA recognition 4-272 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-272 |
|---|---|
| Designation | Standard No. 63-2013 |
| Title | Root Canal Barbed Broaches and Rasps |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard specifies requirements and test methods for root canal instruments for hand use utilized in endodontic preparation. |
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: