FDA-recognized standard · Dental/ENT

ISO 13397-2: Dentistry - Periodontal curettes dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)]

4-385: ISO 13397-2 Second edition 2005-06 [Including AMD1:2012].

Yes. FDA recognizes ISO 13397-2 Second edition 2005-06 [Including AMD1:2012] as recognition 4-385, entered 2026-05-25.

Recognized editions of ISO 13397-2

FDA recognitions of ISO 13397-2, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
4-385	ISO 13397-2 Second edition 2005-06 [Including AMD1:2012]	2026-05-25	Complete	—

FDA lists these classification regulations against ISO 13397-2: 21 CFR 872.4565.

6 FDA product codes cite ISO 13397-2, including EKC, EKE, EKT, EMK, EMN.

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.