(131 days)
3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.
The Conical Angled Abutments are designed to interface with 3i's internal and external connected implants. They will be available in 17° and 25° angles. The seating surface will be 4.1mm and 5.0mm diameters and the transmucosal tissue heights will be 2.0mm and 4.0mm. They will be manufactured out of Titanium Alloy.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental device (Conical Angled Abutments), and it primarily focuses on describing the device, its classification, predicate devices, and an FDA letter confirming substantial equivalence.
It explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act." This indicates that the approval for this device was based on substantial equivalence to a legally marketed predicate device, rather than meeting specific performance criteria demonstrated through a clinical study.
Therefore, I cannot provide the requested table or details about studies, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given text.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)