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Soft Reline is a visible light cure soft reline material for removable dentures. It is intended for short-term use of at least 30 days.

Soft Reline is a visible light cure soft reline material for removable dentures.

The provided document is an FDA 510(k) clearance letter for a medical device called "Liner II: Soft Reline Liquid." This document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria or a study demonstrating achievement of those criteria.

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