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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 4-244
ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
Scope/Abstract
This International Standard specifies methods for measuring the dimensional characteristics, neck strength and surface roughness of dental rotary instruments, such as burs, cutters, polishers, diamond and abrasive instruments.

This International Standard does not provide test methods for the characteristics of materials used for dental rotary instruments.

NOTE For testing of these characteristics, see the respective product standards.

This International Standard is not applicable to dental root-canal instruments (see ISO 3630-1).

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
§872.6640 Unit, Operative Dental Class 1 EIA
§872.4200 Controller, Foot, Handpiece And Cord Class 1 EBW
§872.4200 Handpiece, Air-Powered, Dental Class 1 EFB
§872.4200 Handpiece, Air-Powered, Root Canal Irrigation Class 1 NYL
§872.4200 Handpiece, Belt And/Or Gear Driven, Dental Class 1 EFA
§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
§872.4120 Dental Stereotaxic Instrument Class 2 PLV
§872.4120 Drill, Bone, Powered Class 2 DZI
§872.4120 Driver, Wire, And Bone Drill, Manual Class 2 DZJ
§872.4120 Handpiece, Rotary Bone Cutting Class 2 KMW
§872.4120 Saw, Bone, Ac-Powered Class 2 DZH
§872.3240 Bur, Dental Class 1 EJL
§872.3240 Bur, Diamond Coated, Reprocessed Class 1 NME
§872.4535 Instrument, Diamond, Dental Class 1 DZP
§872.4535 Instrument, Diamond, Dental, Reprocessed Class 1 NLD
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions, Issued May 2007.
FDA Technical Contacts
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Michael Mendelson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6280
  michael.mendelson@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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