Recognized standard
13397-3 First edition 1996-09
FDA recognition 4-386 · ISO · Dental/ENT
Key facts
| Recognition number | 4-386 |
|---|---|
| Designation | 13397-3 First edition 1996-09 |
| Title | Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | Gives the dimensions for H-type dental scalers. |
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: