• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 4-139
Standard
ANSI ADA Standard 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

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 Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
-
-