(49 days)
For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation. Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.
MD-Temp™ is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative. The formula for MD-Temp™ is listed in Attachment I. It is available in white (tooth-like) or pink (gum-like) colors in small jars (e.g. 40 gm.) jars, individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations.
The provided text is a 510(k) summary for the MD-Temp™ temporary dental restorative and the FDA's clearance letter. It states that "No performance standards under Section 514" have been established. It also does not explicitly detail a specific study with acceptance criteria and results. Instead, it relies on substantial equivalence to predicate devices, noting that the "Physical properties, compositions, and use of MD-Temp™ are similar to predicate 510(k)s." The only specific mention of performance is that the "material meets ISO 10993 for biocompatibility."
Therefore, based on the provided document, I cannot fulfill your request for a table of acceptance criteria and reported device performance directly from a standalone study, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The information you are requesting typically comes from a detailed "performance testing" or "clinical study" section, which is not present in this 510(k) summary. The summary focuses on comparing the new device to existing predicate devices based on descriptions and previous clearances rather than presenting new, detailed performance data with specific acceptance criteria that the device meets.
§ 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.