(43 days)
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
Concept HP Enamel is heat and pressure cured resin material to be used for the Concept in indirect inlay and onlay dental restorations.
The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene
Not Found
The provided document is a 510(k) Pre-market Notification letter from the FDA for a dental device (Concept HP Add-On and Concept HP Enamel). It confirms substantial equivalence to a predicate device for marketing purposes.
However, this document does not contain any information regarding:
- Acceptance criteria for device performance.
- The details of a study that proves the device meets specific acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.
Therefore, I cannot provide the requested information based on the given document. This FDA letter simply states that the device is substantially equivalent to existing devices and can be marketed, without detailing performance studies or their results.
§ 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.