Recognized standard
13397-2 Second edition 2005-06 [Including AMD1:2012]
FDA recognition 4-385 · ISO · Dental/ENT
Key facts
| Recognition number | 4-385 |
|---|---|
| Designation | 13397-2 Second edition 2005-06 [Including AMD1:2012] |
| Title | Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 13397-2:2005 specifies the designs and dimensions for Gr-type periodontal curettes. |
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: