FDA-recognized standard · Dental/ENT
ISO 8325: Dentistry - Test methods for rotary instruments
Yes. FDA recognizes ISO 8325 Third edition 2023-03 as recognition 4-317, entered 2023-12-18.
Recognized editions of ISO 8325
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-317 | ISO 8325 Third edition 2023-03 also ANSI ADA Standard No. 180-2024 | 2023-12-18 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 8325: 21 CFR 872.3240, 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4535, 21 CFR 872.6640.
Product codes that cite ISO 8325
17 FDA product codes cite ISO 8325, including DZH, DZI, DZJ, DZP, EBW.
- DZH
- DZI Drill, Bone, Powered
- DZJ Driver, Wire, And Bone Drill, Manual
- DZP
- EBW Controller, Foot, Handpiece And Cord
- EFA
- EFB Handpiece, Air-Powered, Dental
- EGS Handpiece, Contra- And Right-Angle Attachment, Dental
- EIA Unit, Operative Dental
- EJL
- EKX Handpiece, Direct Drive, Ac-Powered
- EKY
- KMW
- NLD
- NME
- NYL
- PLV Dental Stereotaxic Instrument
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.