(80 days)
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
This document is a 510(k) summary for the XR Primer 2, a light-cured cavity primer. It does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The document primarily focuses on establishing substantial equivalence for the XR Primer 2 to a legally marketed predicate device (the original XR Primer formulation). This type of submission to the FDA (510(k)) generally relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials to establish new performance metrics against pre-defined acceptance criteria.
Therefore, I cannot extract the requested information from the provided text regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or related effect size.
- Standalone performance study.
- 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.