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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 4-276
Standard
ISO 14457 Second edition 2017-10
Dentistry - Handpieces and motors
Scope/Abstract
ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging.

ISO 14457:2017 is applicable to the following:
a) straight and angle handpieces;
b) high-speed air turbine handpieces;
c) air motors;
d) electrical motors;
e) prophy handpieces.

ISO 14457:2017 is not applicable to the following:
- intraoral camera handpieces;
- powered polymerization handpieces;
- air-powered scalers;
- electrical-powered scalers;
- powder jet handpieces;
- multifunction handpieces (syringes).

NOTE See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.8.1 General "The following requirements are not applicable for air motors and high-speed air turbine handpieces."
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.

This standard is recognized in part because:
Clause 5.8.1 is in conflict with an existing published final guidance, see Section 7 Performance Testing, of the guidance #1 listed below.
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FDA recognition of ISO 14457 First edition 2012-09 [Rec# 4-206] will be superseded by recognition of ISO 14457 Second edition 2017-10 [Rec# 4-276].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*
1. Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submission, Issued May 2007.

2. Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued June 2017.
FDA Technical Contacts
 Leah Royce
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6268
  leah.royce@fda.hhs.gov
 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
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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