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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 4-226
Standard
ISO 10650 First Edition 2015-09-01
Dentistry - Powered polymerization activators
Scope/Abstract
ISO 10650:2015 specifies requirements and test methods for powered polymerization activators in the 385 nm - 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This International Standard applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this International Standard.

ISO 10650:2015 does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures, or other oral dental appliances. This International Standard takes priority over IEC 60601 where specified in the individual clauses of this International Standard.

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.
Transition Period
FDA recognition of ISO 10650 First edition 2015-09-01 [Rec# 4-226] will be superseded by recognition of ISO 10650 Second edition 2018-08 [Rec# 4-252]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-226] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 4-226] will not be accepted.
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, Issued March 27, 2006.
FDA Technical Contacts
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Sheena Green
  FDA/OMPT/CDRH/OC/DBM/BCB II/
  301-796-6279
  sheena.green@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
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