FDA-recognized standard · Dental/ENT
ISO 13397-1: Periodontal curettes dental scalers and excavators - Part 1: General requirements
Yes. FDA recognizes ISO 13397-1 First edition 1995-12 as recognition 4-384, entered 2026-05-25.
Recognized editions of ISO 13397-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-384 | ISO 13397-1 First edition 1995-12 | 2026-05-25 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 13397-1: 21 CFR 872.4565.
Product codes that cite ISO 13397-1
6 FDA product codes cite ISO 13397-1, including EKC, EKE, EKT, EMK, EMN.
- EKC
- EKE
- EKT
- EMK
- EMN
- EMS
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.