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510(k) Data Aggregation
(82 days)
The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Light Tip." It discusses regulatory aspects, such as substantial equivalence to a predicate device, and general controls, but it does not include any performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth information. It only provides the indications for use of the device.
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