Recognized standard
7405 Third edition 2018-10 Corrected version 2018-12
FDA recognition 4-261 · ISO · Dental/ENT
Key facts
| Recognition number | 4-261 |
|---|---|
| Designation | 7405 Third edition 2018-10 Corrected version 2018-12 |
| Title | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into… |
At a glance
- 10–99 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: