(41 days)
CLEAFIL SE BOND is indicated for the following applications:
- Direct filling restorations using light-curing composite or compomer
- Cavity sealing as a pretreatment for indirect restorations
- Treatment of hypersensitive and/or exposed root surfaces
- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
I am sorry, but the provided text is a 510(k) summary for a dental adhesive (CLEARFIL SE BOND), which focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not describe a study that involves acceptance criteria for device performance in the context of diagnostic accuracy, AI, or human reader effectiveness.
Therefore, I cannot extract the information required to answer your request, such as a table of acceptance criteria and reported device performance related to a diagnostic study, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 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.