(71 days)
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. Life 2 is a two-part, base/catalyst paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Regular Set and Fast Set.
The provided text is a 510(k) summary for a dental device called "Life 2". It outlines the device description, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely for regulatory submission and does not detail performance testing results.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.