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510(k) Data Aggregation
(47 days)
Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry.
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The provided text does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification approval letter for a device named "Apollo 9500" from the Food and Drug Administration (FDA).
The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use: "Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry."
Therefore, I cannot extract the requested information from this document.
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