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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 4-139
Standard
ANSI ADA Specification No. 48:2004 (R2015)
Visible Light Curing Units
Scope/Abstract
This standard gives requirements and test methods for visible light curing units with powered tungsten-halogen lamps in the blue wavelength region intended for chairside use in polymerization of dental resin-based materials. This standard is also applicable to rechargeable battery-powered visible light curing units. It does not cover powered visible light curing units used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.
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
§872.6070 Activator, Ultraviolet, For Polymerization Class 2 EBZ
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff Dental Curing Lights - Premarket Notification [510(k)] Submissions. Document issued on: March 27, 2006
FDA Technical Contact
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
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