(94 days)
The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials.
The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a product called "Bosworth Dentin Resin," dated September 1, 2006.
It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the specified indications for use. This letter is an official notification of market clearance based on substantial equivalence, not a detailed report of performance testing against specific acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.