(89 days)
Telio CS Inlay:
Temporization of deep inlay preparations with paralle! walls
Sealing of implant screw access holes
Relining of pre-fabricated, temporary crowns and bridges made of polycarbonate or methacrylates.
Telio CS Onlay:
Temporization of large, shallow cavities (onlay preparations).
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The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Telio® CS Inlay and Telio® CS Onlay." This document is a regulatory clearance letter for a dental material (temporary crown and bridge resin), not a study report or clinical trial demonstrating the performance of a medical device against acceptance criteria with AI assistance.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details, and AI-assisted improvements cannot be extracted from this document as it pertains to a different type of medical product and regulatory pathway.
This document confirms substantial equivalence of a temporary dental material to a predicate device, based on its indications for use and material properties, not on a machine learning model's performance.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.