(98 days)
A dual-cure, tooth shade, resin composite for the restoration of Class I, II, III, IV and V cavities in permanent and deciduous teeth.
A radiopaque, dual-cure, two-paste, resin composite restorative for use in all class cavities as the final restration. May also be used as a core material. It is supplied in 25ml, auto-mixing cartridges and employs components commonly used in predicate devices.
This is a 510(k) premarket notification for a medical device. The provided text is heavily focused on the administrative aspects of the submission and the FDA's response, rather than a detailed technical study section. Therefore, the requested information about acceptance criteria, device performance, and study details is not present in the provided document.
The document discusses:
- Submission details (submitter, contact, date, trade name, common name, classification, equivalence, description/intended use).
- FDA's letter of substantial equivalence.
- Indications for Use.
There is no section detailing a study that proves the device meets acceptance criteria. The document explicitly states: "Although biocompatibility testing was deemed to be non-essential, lab results are included as part of this submission. These indicate the material is biocompatible and non-mutagenic." This suggests that extensive performance studies (especially clinical ones) were not central to this particular 510(k) submission, likely due to the nature of the device and its substantial equivalence to predicate devices.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, types of ground truth, or training set details.
§ 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.