(80 days)
The SternOmega Dental Composite System is indicated for dental filling of cavities.
The SternOmega Composite LC is indicated for filling of all classes of cavities.
The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.
The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.
The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.
The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.
The provided text is a 510(k) Summary for a dental composite system. It does not contain information about specific acceptance criteria, device performance metrics, or a study that proves the device meets those criteria.
Instead, it states that the submission is a "Special 510(k): Abbreviated 510(k)" and that Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.
This means that the manufacturer is asserting substantial equivalence to predicate devices based on meeting the general requirements outlined in that FDA guidance document, rather than conducting a new, detailed performance study with explicit acceptance criteria for this specific device. The approval letter further confirms this by stating the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot fill out the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) summary focuses on demonstrating equivalence to existing products rather than presenting new performance data against novel acceptance criteria.
To answer your request thoroughly, a different type of document (e.g., a detailed clinical or performance study report) would be needed.
§ 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.