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The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

The subject device is packaged with the following: D-Lux+ Handpiece, D-Lux+ Charger, Light Probe, Light Protector, C-Battery, Adapter, Power Cord, Disposable Sheaths(200ea/Box), Instruction Manual. The D-Lux+ Handpiece turns on/off the power, sets the mode and time, and controls the operation. The handpiece includes a battery. The C-Battery is included in the handpiece and supplies power to the handpiece. The D-Lux+ Charger charges the battery when the handpiece is placed on this device. The Adapter supplies power to the charger. The Power Cord is a cord to conduct power to an adapter. Disposable sheaths protect products and patients from contamination. Disposable, so reuse is prohibited. The Light Probe is connected to the handpiece so that the light emitted from the light source (LED) reaches the restoration. The Light Protector is inserted into the handpiece and used to protect the eyes from emitted light. The Instruction Manual is a document that describes information that the user needs to know, such as precautions, operating procedures, and how to use the device.

{"1": "No specific acceptance criteria or performance metrics were reported in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on similar characteristics and non-clinical testing.", "2": "The document states "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no sample size for a test set or data provenance can be provided.", "3": "No clinical data was collected, thus no experts were used to establish ground truth for a test set.", "4": "No clinical data was collected, thus no adjudication method was used.", "5": "No MRMC comparative effectiveness study was done as no clinical data was collected.", "6": "A standalone study was not done; the evaluation relied on non-clinical bench testing to demonstrate conformance with harmonized standards and substantial equivalence.", "7": "The ground truth for demonstrating substantial equivalence appears to be based on compliance with harmonized standards and successful non-clinical bench testing, rather than expert consensus, pathology, or outcomes data.", "8": "No specific training set size is mentioned as no clinical data was collected or used for an algorithm.", "9": "Not applicable, as no training set was used for an algorithm."}

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