Recognized standard
13397-1 First edition 1995-12
FDA recognition 4-384 · ISO · Dental/ENT
Key facts
| Recognition number | 4-384 |
|---|---|
| Designation | 13397-1 First edition 1995-12 |
| Title | Periodontal curettes, dental scalers and excavators - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | Specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators. |
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: