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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 4-359
Standard
ANSI ADA  Standard No. 159-2024
Dentistry - Coiled Springs for Use in Orthodontics
Scope/Abstract
This standard applies to coiled springs for use in orthodontic appliances. This standard gives details of methods to compare the physical and mechanical behavior of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

This is a modified version of ISO 17254 First edition 2016-07 Dentistry - Coiled springs for use in orthodontics and ISO 17254:2016/ Amendment 1:2020.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.5410 Spring, Orthodontic Class 1 ECO
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  Michael.Adjodha@fda.hhs.gov
 Ran Huo
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  240-402-6705
  Ran.Huo@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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