Recognized standard
15098 Second edition 2024-07
FDA recognition 4-389 · ISO · Dental/ENT
Key facts
| Recognition number | 4-389 |
|---|---|
| Designation | 15098 Second edition 2024-07 |
| Title | Dentistry - Dental tweezers |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies general requirements and test methods for metallic dental tweezers of Meriam type and College type. This document is not applicable to anatomical tweezers and surgical tweezers. |
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: