(90 days)
Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
- Only use Variolink Esthetic LC for restorations with a low thickness of
Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)
The provided text describes a 510(k) premarket notification for a dental device, Variolink® Esthetic. It includes a comparison to a predicate device and a brief summary of testing performed. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving acceptance criteria were met as typically found in clinical trial reports or detailed performance studies for AI/medical imaging devices.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on chemical composition, physical properties, and indications for use, rather than presenting a detailed performance study against specific acceptance criteria for an AI-based device.
Therefore, I cannot directly answer your request about acceptance criteria and the study proving the device meets them in the format you provided because the necessary details are not present in the given text.
Based on the information provided, here's what can be extracted and what is missing:
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance: The document mentions that the device has been tested and designed in accordance with certain ISO standards (ISO 4049:2009 for physical properties and EN ISO 10993-1:2009 / EN ISO 7405:2008 for biocompatibility). However, it does not list specific acceptance criteria values (e.g., "flexural strength must be > X MPa") or the actual reported performance values (e.g., "flexural strength was Y MPa") against those criteria. It only states that the device was designed and tested in accordance with these standards.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/imaging device requiring expert ground truth for interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For physical/chemical properties, the "ground truth" would be the standard measurement methods defined by the ISO/EN standards. For biocompatibility, it's about meeting the safety profiles outlined in the standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is present:
- Device Name: Variolink® Esthetic
- Predicate Device: Variolink II (K971372)
- Type of tests performed:
- Physical properties (in accordance with ISO 4049:2009): film thickness, Depth of Cure, sensitivity to ambient light, working time, flexural strength, water sorption, solubility, and radiopacity.
- Biocompatibility testing (in accordance with EN ISO 10993-1:2009 and EN ISO 7405:2008).
- Conclusion: The device is substantially equivalent to the predicate device based on comparison of chemical composition, physical properties, and indications for use.
To fully answer your question, information typically found in detailed test reports or clinical studies would be needed, which is beyond the scope of this 510(k) summary document.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.