Recognized standard
18397 Second edition 2025-07
FDA recognition 4-355 · ISO · Dental/ENT
Key facts
| Recognition number | 4-355 |
|---|---|
| Designation | 18397 Second edition 2025-07 |
| Title | Dentistry - Powered scaler |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. This document also… |
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: