Recognized standard
13397-5 First edition 2015-09
FDA recognition 4-387 · ISO · Dental/ENT
Key facts
| Recognition number | 4-387 |
|---|---|
| Designation | 13397-5 First edition 2015-09 |
| Title | Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 13397-5:2015 specifies the designs and dimensions for Jacquette 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: