Recognized standard
14457 Second edition 2017-10 Standard No. 35-2019
FDA recognition 4-276 · ISO · Dental/ENT
Key facts
| Recognition number | 4-276 |
|---|---|
| Designation | 14457 Second edition 2017-10 Standard No. 35-2019 |
| Title | Dentistry - Handpieces and motors Dental Handpieces and Motors |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging. ISO 14457:2017 is… |
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: