FDA-recognized standard · Dental/ENT
ISO 3964: Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
Yes. FDA recognizes ISO 3964 Third edition 11-2016 as recognition 4-269, entered 2020-12-21.
Recognized editions of ISO 3964
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-269 | ISO 3964 Third edition 11-2016 also ANSI ADA Standard No. 158-2020 | 2020-12-21 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 3964: 21 CFR 872.4200, 21 CFR 872.6640.
Product codes that cite ISO 3964
8 FDA product codes cite ISO 3964, 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
- 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.