FDA-recognized standard · Dental/ENT
ISO 1797: Dentistry - Shanks for rotary and oscillating instruments
Yes. FDA recognizes ISO 1797 Third Edition 2017-05 as recognition 4-281, entered 2021-06-07.
Recognized editions of ISO 1797
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-281 | ISO 1797 Third Edition 2017-05 also ANSI ADA Standard No. 179-2020 | 2021-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 1797: 21 CFR 872.3240, 21 CFR 872.4120, 21 CFR 872.4200, 21 CFR 872.4840, 21 CFR 872.6640.
Product codes that cite ISO 1797
15 FDA product codes cite ISO 1797, including DZH, DZI, DZJ, EBW, EFA.
- DZH
- DZI Drill, Bone, Powered
- DZJ Driver, Wire, And Bone Drill, Manual
- 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
- ELB
- KMW
- NME
- 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.