| ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators |
| Recognition Number | Dental/ENT |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 4-252 |
| 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.
This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document 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 standard.
This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.
| 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. |