• 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 056 Date of Entry 06/07/2021 
FR Recognition Number 4-281
Standard
ISO  1797 Third Edition 2017-05
Dentistry - Shanks for rotary and oscillating instruments
Identical Adoption
ANSI ADA Standard No. 179-2020
Shanks for Rotary and Oscillating Instruments
Scope/Abstract
ISO 1797:2017 specifies the requirements for dimensions and material properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements.

ISO 1797:2017 is not applicable to tips fixed to the handpiece with a screw, e.g. scaler tips.

Information about the location of marking is also given. Annex A on quality control is included in order to ensure a high quality level.
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
§872.3240 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
§872.4200 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
§872.4840 Scaler, Rotary Class 2 ELB
§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
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.
-
-