Demi Pro

The Demi Pro is a pen-style cordless LED curing light for polymerizing light-cured dental materials, powered by a rechargeable lithium-ion battery. It emits high-intensity blue light (380-515 nm wavelength) to activate photo initiators in dental resins and can also provide illumination for visualization during oral procedures.

The device operates using LED light sources with comparable wavelength range (380-515 nm) and similar intensity levels to predicate devices. It features an anodized aluminum housing with thermoplastic and optical polymer components, a two-button control system with visual indicators, multiple curing modes (Standard, High, Ortho, and Diagnosis), and a magnetized lens attachment system for accessory interchange.

ISO 10993-1:2018 for biocompatibility evaluation; FDA Guidance on 'Use of International Standard ISO 10993, Biological evaluation of medical devices Part 1' dated September 20, 2020; and the FDA Guidance for Industry and FDA Staff - Dental Curing Lights - Premarket Notification [510(k)] Submissions.

The Demi Pro is substantially equivalent to VALO X and Delight Ortho because all three devices use LED light sources for polymerization within the same wavelength range, demonstrate equivalent light intensity and polymerization depth performance, employ similar materials and construction methods, and share comparable operating principles and power sources (lithium-ion batteries).