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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 4-229
Standard
IEC 80601-2-60 Edition 1.0 2012-02
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Scope/Abstract
This International Standard applies to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces and dental operating lights, hereafter referred to as dental equipment.

Excluded are amalgamators, sterilizers and dental X-ray equipment.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Sub-clause 201.4.3, the Sentence, "DENTAL EQUIPMENT does not have ESSENTIAL PERFORMANCE."
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:
Sub-clause 201.4.3 is in conflict with another recognized standard, see ANSI/AAMI ES60601-1 listed below.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§872.6640 Unit, Operative Dental Class 1 EIA
§872.6070 Activator, Ultraviolet, For Polymerization Class 2 EBZ
§872.4850 Scaler, Ultrasonic Class 2 ELC
§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
§872.4120 Handpiece, Rotary Bone Cutting Class 2 KMW
Relevant FDA Guidance and/or Supportive Publications
1. Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions, Issued May 2, 2007.

2. ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
FDA Technical Contacts
 Joel Anderson
  FDA/OMPT/CDRH/ODE/DAGID/DEDB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Lauren Giles
  FDA/OMPT/CDRH/ODE/DAGID/DEDB/
  301-796-9552
  lauren.giles@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Dental/ENT
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