Recognized standard
Standard No. 95-2020
FDA recognition 4-358 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-358 |
|---|---|
| Designation | Standard No. 95-2020 |
| Title | Endodontics Instruments - Enlargers |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard specifies requirements for enlargers not cited in ANSI/ADA Standard No. 28, ANSI/ADA Standard No. 63, ANSI/ADA Standard No. 71, or ANSI/ADA Standard No. 101. This standard specifies requirements for size, marking, product designation, safety designation, safety considerations, 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: