| ISO 10650 First Edition 2015-09-01 Dentistry - Powered polymerization activators |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-226 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6070 | Activator, Ultraviolet, For Polymerization | Class 2 | EBZ |
| Guidance for Industry and FDA Staff: Dental Curing Lights - Premarket Notification [510(k)] Submissions, Issued March 27, 2006. |