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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 4-206
ISO 14457 First edition 2012-09-15
Dentistry - Handpieces and motors
ISO 14457:2012 is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.

ISO 14457:2012 is applicable to:
1.straight and geared angle handpieces, including handpiece attachments;
2.high-speed air turbine handpieces;
3.air motors;
4.electrical motors;
5.prophy handpieces.
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FDA recognition of ISO 14457 First edition 2012-09 [Rec# 4-206] will be superseded by recognition of ISO 14457 Second edition 2017-10 [Rec# 4-276]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-206] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 4-206] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.4120 Handpiece, Rotary Bone Cutting Class 2 KMW
§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
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007
FDA Technical Contacts
 Michael Mendelson
 Leah Royce
 Lauren Giles
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.