(83 days)
The Demi is an L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The Demi is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cured materials by dental professionals. The Demi consists of an LED curing handpiece and charging system. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output, fan, and audible beep timing. The Demi utilizes two pushbutton triggers, one to select the curing mode and another to activate the LED curing output.
This document describes a 510(k) premarket notification for a dental device, the Demi LED Curing Light. It does not contain information about acceptance criteria, device performance studies, or AI/ML evaluations. Therefore, I cannot generate the requested table and study details.
The provided text focuses on:
- Device Identification: Trade Name (Demi), Common Name (L.E.D. Curing Light), Classification Name (Ultraviolet activator for polymerization).
- Intended Use: Polymerization of visible light-cured materials by dental professionals.
- Substantial Equivalence: Claims substantial equivalence to the Kerr Corporation, L.E. Demetron II.
- FDA Communication: Official letter from the FDA confirming review and substantial equivalence determination, allowing the device to be marketed.
To fulfill your request, I would need a different type of document that details performance testing, clinical study results, or AI/ML validation data.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.