Recognized Consensus Standards: Medical Devices

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

Identical Adoption

ANSI ADA Standard No. 35-2019
Dental 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.

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
§872.4200	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
§872.6640	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)] 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.

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

Michael Mendelson

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6280

michael.mendelson@fda.hhs.gov

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