Search Results

Ionolux Pro is intended for the following applications:

1. Restorations class III and V, especially cervical fillings and root caries
2. Fillings on deciduous teeth
3. Small class I fillings
4. Temporary fillings
5. Core build-up
6. Lining

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Ionolux Pro," which is a "Tooth Shade Resin Material" used in dentistry. This document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It details the indications for use of the device but offers no performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Ask a specific question about this device

lonolux is intended for the following applications:

1. Restorations class III and V, especially cervical fillings and root caries
2. Fillings on deciduous teeth
3. Small class I fillings
4. Temporary fillings
5. Core build-up
6. Lining

Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.

This document describes a 510(k) premarket notification for a dental cement called Ionolux. As such, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive study results against specific performance criteria. The provided text indicates that:

• Technological characteristics: "All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.)"
• Safety and effectiveness: "The prior use of all of the components of Ionolux in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional blocompatibility studies with the final formulation are not necessary. We believe that the prio use of the components of lonolux in legally marketed devices and the performance data and results provided support the safety and effectiveness of lonolux for the intended use."

This essentially states that the device is considered safe and effective because its components are already used in a legally marketed predicate device, and therefore, extensive new testing (like a standalone performance study with detailed acceptance criteria) was deemed unnecessary for this 510(k) submission.

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

Ask a specific question about this device