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The Flexiscope Optomodul is indicated for use during dental in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.

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I am unable to answer your request. The provided text is a 510(k) premarket notification letter from the FDA to Schoelly Fiberoptic, GmbH regarding their Flexiscope Optomodul device. This letter indicates that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market.

However, a 510(k) notification does not contain the acceptance criteria or the study that proves the device meets those criteria. Instead, it's a notification seeking to demonstrate that a new device is as safe and effective as a legally marketed predicate device. The detailed performance data and acceptance criteria would be part of the technical documentation submitted by the manufacturer to the FDA, but they are not included in this letter.

Therefore, I cannot extract the information required to populate the table and answer your questions based on the provided text.

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