(101 days)
Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.
Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.
Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
I am sorry, but the provided text content does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental bonding agent called "Bosworth Bond" (K043170). It discusses the device's substantial equivalence to predicate devices and outlines regulatory requirements. It does not include:
- A table of acceptance criteria and device performance.
- Details about sample sizes, data provenance, or the number/qualifications of experts.
- Adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on ground truth types, training set sizes, or how training set ground truth was established.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.