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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 055 Date of Entry 12/21/2020 
FR Recognition Number 4-266
Standard
ISO  19023 First edition 2018-02
Dentistry - Orthodontic anchor screws
Identical Adoption
ANSI ADA Standard No. 178-2019
Orthodontic Anchor Screws
Scope/Abstract
ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment.
ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information.
NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.
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.
ASCA Notes
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
§872.3640 Implant, Endosseous, Orthodontic Class 2 OAT
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
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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