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FDA-recognized standard · Dental/ENT

ISO 13397-5: Dentistry - Periodontal curettes dental scalers and excavators - Part 5: Jacquette scalers

Yes. FDA recognizes ISO 13397-5 First edition 2015-09 as recognition 4-387, entered 2026-05-25.

Recognized editions of ISO 13397-5

FDA recognitions of ISO 13397-5, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
4-387 ISO 13397-5 First edition 2015-09 2026-05-25 Complete —

Regulations

FDA lists these classification regulations against ISO 13397-5: 21 CFR 872.4565.

Product codes that cite ISO 13397-5

6 FDA product codes cite ISO 13397-5, 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.