• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
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
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.
Transition Period
FDA recognition of ISO 8325 Second edition 2004-09 [Rec# 4-244] will be superseded by recognition of ISO 8325 Third edition 2023-03 [Rec# 4-317]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-244] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-244] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3240 Bur, Dental Class 1 EJL
§872.3240 Bur, Diamond Coated, Reprocessed Class 1 NME
§872.4120 Saw, Bone, Ac-Powered Class 2 DZH
§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 Dental Stereotaxic Instrument Class 2 PLV
§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
§872.4535 Instrument, Diamond, Dental Class 1 DZP
§872.4535 Instrument, Diamond, Dental, Reprocessed Class 1 NLD
§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. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, 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
 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.