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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 4-267
ISO 21606 First edition 2007-06
Dentistry - Elastomeric auxiliaries for use in orthodontics
U.S. Identical Adoption
ANSI ADA Standard No. 105-2010 (R2015)
Orthodontic Elastomeric Materials
ISO 21606:2007 is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.
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 Band, Elastic, Orthodontic Class 1 ECI
§872.5500 Headgear, Extraoral, Orthodontic Class 2 DZB
FDA Technical Contact
 Bobak Shirmohammadi
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.