Recognized standard
13017 Second edition 2020-07 Standard No. 201-2022
FDA recognition 4-380 · ISO · Dental/ENT
Key facts
| Recognition number | 4-380 |
|---|---|
| Designation | 13017 Second edition 2020-07 Standard No. 201-2022 |
| Title | Dentistry - Magnetic attachments Dentistry - Magnetic Attachments |
| 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 requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic… |
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: