Recognized standard
3630-2 Fourth edition 2023-02
FDA recognition 4-361 · ISO · Dental/ENT
Key facts
| Recognition number | 4-361 |
|---|---|
| Designation | 3630-2 Fourth edition 2023-02 |
| Title | Dentistry - Endodontic instruments - Part 2: Enlargers |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7. This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the… |
At a glance
- 1–9 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: