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510(k) Data Aggregation
(77 days)
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique.
Cold curing:
-upper and lower full dentures (pour technique)
-completion of partial dentures
-repairs
Heat Cure:
- upper and lower full dentures (presspack technique)
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique.
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to J.F. Jelenko & Company, Incorporated, concerning their JelDent™ Multicryl device. This type of document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input. This document only states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.
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