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Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for temporary crown- and bridge restorations used for all techniques, i.e. with matrices or templates as well as Direct application in the dental laboratory.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental material (Cool Temp Natural), not a study report for an AI/ML medical device.

Therefore, I cannot extract any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested. The document does not contain any of these elements.

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For the cementation/affixing of metal and/or ceramic orthodontic brackets to teeth.

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This document is a 510(k) premarket notification letter from the FDA regarding the "Cool Bond Light Cured Bracket Adhesive System." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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