(30 days)
- filling minimally invasive cavities of all classes
- filling small class I cavities and extended fissure sealing
- filling class II-V cavities including V-shaped defects and cervical caries -
- blocking out undercuts -
- lining or coating cavities
- repairing fillings and veneers .
- luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -
Not Found
The provided document is an FDA 510(k) clearance letter for a dental material (N-Hybrid-Composite LC Flow). It does not contain information about acceptance criteria, study details, or performance data in the context of an AI/ML device. Therefore, I cannot extract the requested information.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to a predicate device.
- Listing the indications for use of the dental composite material.
- Emphasizing compliance with FDA regulations for medical devices.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission document that details the performance testing of an AI/ML device.
§ 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.