(89 days)
Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:
- Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
- Repair of dental restorations of ceramic, composites and/or metal alloys;
- Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "Light Cure Adhesive" device, which is a dental bonding agent. It discusses regulatory matters, such as substantial equivalence, general controls, and good manufacturing practices.
It does not include details about:
- Acceptance criteria table and reported device performance for a study proving the device meets the criteria.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
This document is a regulatory approval, not a clinical or performance study report for an AI/software-based medical device. Therefore, I cannot extract the requested information from the given 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.