(147 days)
e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure.
e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for a dental resin and curing system, primarily focusing on demonstrating substantial equivalence to a predicate device.
It describes the device, its intended use, and states that its technological characteristics are "essentially identical" to the predicate device, VITA CAD TEMP, except for the manufacturing method (additive vs. subtractive). The document primarily outlines the regulatory approval process and confirms that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table or details about a study proving acceptance criteria as this information is not present in the given text.
The following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the study design.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set or how ground truth for the training set was established.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.