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The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.

The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.

The provided text does NOT currently contain information about acceptance criteria, device performance, sample sizes used, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the QuickSmile Whitening Light.

The document is a 510(k) Pre-Market Notification for the QuickSmile Whitening Light, which focuses on demonstrating substantial equivalence to a predicate device, the South Beach Smile Light Whitening System. It describes the device, its intended use, and technological characteristics. The FDA's response letter in the document primarily confirms the substantial equivalence determination for the light source component but explicitly states that the determination does not apply to the whitening component(s) of the device (specifically mentioning malachite green oxalate) because the regulatory status of such tooth whitening preparations was unresolved at the time.

To answer your request, the provided input would need to contain a study report or clinical trial data presenting performance metrics against specific acceptance criteria. This document does not include such a study.

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