(19 days)
OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct Situations, I.C., composite to enailer and/or dentin, composite repair, porcelain repair, composite to mount, analgain commons, inlays, crowns, Maryland bridges, post cementation.
The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding and bonding composite core build-up materials. Additionally, because the device contains a dual cure catalyst, OptiBond Solo Plus can be used for indirect situations as well including veneers, onlays, inlays, crowns, Maryland bridges and post cementation.
The provided text is a 510(k) Summary of Safety and Effectiveness for a dental bonding agent called "OptiBond Solo Plus." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove device performance through a detailed study comparing the device against those criteria.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
- Standalone performance information.
- Specific details on how ground truth was established for testing or training sets.
The document primarily focuses on:
- Device Name: OptiBond Solo Plus
- Intended Use: Bonding in direct situations (composite to enamel/dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, core build-up materials) and indirect situations (veneers, onlays, inlays, crowns, Maryland bridges, post cementation).
- Predicate Device: Dentsply International, Prime & Bond 2.1
- Claim of Substantial Equivalence: The device functions in a similar manner and is intended for the same use as the predicate device.
To obtain the requested information, one would typically need access to the full 510(k) submission, including any performance studies or validation reports, which are not present in this summary.
§ 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.