FDA-recognized standard · Dental/ENT
ISO 14457: Dentistry - Handpieces and motors
Yes. FDA recognizes ISO 14457 Second edition 2017-10 as recognition 4-276, in part, entered 2021-06-07.
Recognized editions of ISO 14457
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-276 | ISO 14457 Second edition 2017-10 also ANSI ADA Standard No. 35-2019 | 2021-06-07 | Partial | — |
What FDA does not recognize in ISO 14457 Second edition 2017-10
Recognition 4-276 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.8.1 General "The following requirements are not applicable for air motors and high-speed air turbine handpieces."
Regulations
FDA lists these classification regulations against ISO 14457: 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.6640.
Product codes that cite ISO 14457
9 FDA product codes cite ISO 14457, including EBW, EFA, EFB, EGS, EIA.
- EBW Controller, Foot, Handpiece And Cord
- EFA
- EFB Handpiece, Air-Powered, Dental
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- EIA Unit, Operative Dental
- EKX Handpiece, Direct Drive, Ac-Powered
- EKY
- KMW
- NYL
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.