(13 days)
This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.
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The provided text is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent Incorporated for their Coltolux® LED Curing Light. It approves the device as substantially equivalent to legally marketed predicate devices.
*However, the provided text does not contain any information regarding specific acceptance criteria for device performance, the results of a study demonstrating such performance, or details about sample sizes, ground truth establishment, or expert involvement.
The letter focuses solely on the regulatory approval process and acknowledges the device's substantial equivalence for its stated indications for use, which is the polymerization of intraoral and extraoral restorations containing Camphorquinone.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.