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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 4-269
Standard
ISO  3964 Third edition 11-2016
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
Scope/Abstract
ISO 3964:2016 specifies the coupling between handpieces and motors connected to dental units.

ISO 3964:2016 specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation energy.
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
§872.4200 Controller, Foot, Handpiece And Cord Class 1 EBW
§872.4200 Handpiece, Belt And/Or Gear Driven, Dental Class 1 EFA
§872.4200 Handpiece, Air-Powered, Dental Class 1 EFB
§872.4200 Handpiece, Contra- And Right-Angle Attachment, Dental Class 1 EGS
§872.4200 Handpiece, Direct Drive, Ac-Powered Class 1 EKX
§872.4200 Handpiece, Water-Powered Class 1 EKY
§872.4200 Handpiece, Air-Powered, Root Canal Irrigation Class 1 NYL
§872.6640 Unit, Operative Dental Class 1 EIA
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions , issued May 2007.

2. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued March 2015.

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
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@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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