(36 days)
CLEARFIL TRI-S BOND is indicated for the following applications:
1)Direct restorations using light-cured composite resin
2)Cavity sealing as a pretreatment for indirect restorations
3)Treatment of exposed root surfaces
4)Intraoral repairs of fractured crowns/bridges made of porcelain or composite resin 5)Surface treatment of prosthetic appliances made of porcelain or composite resin
6)Core build-ups using light- or dual- cured composite resin
Not Found
This document is a 510(k) premarket notification letter from the FDA for a dental bonding agent named CLEARFIL TRI-S BOND. It is not an AI/ML device, and therefore the types of studies and acceptance criteria typically associated with AI/ML device evaluations do not apply.
The document discusses substantial equivalence to a predicate device, general controls, and good manufacturing practices, which are standard for traditional medical devices. There is no mention of acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test or training sets, expert adjudication, or MRMC studies, as these concepts are specifically relevant to AI/ML device evaluations and not to this type of dental material.
Therefore, I cannot provide the requested information for this specific device based on the provided document.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.