(183 days)
The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.
The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.
The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics.
The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.
This document does not contain the information required to answer your request. The provided text is a 510(k) summary for dental abutments, which outlines the device description, intended use, and substantial equivalence to predicate devices, but does not describe any studies with acceptance criteria or performance metrics in the way you've outlined.
This submission is for a medical device (Cercon® Abutments) and, based on the provided text, the FDA classified it as substantially equivalent to existing predicate devices. This typically means that the device's technological characteristics and intended use are similar enough to already-approved devices that extensive new clinical studies with defined acceptance criteria and performance reporting might not have been necessary for the 510(k) clearance process itself. The summary states that "We believe that the prior use of the components of the CERCON® ABUTMENTS in legally marketed devices, the provided, and the biocompatibility history support the safety and effectiveness of the CERCON® ABUTMENTS for the indicated uses." This suggests reliance on existing data for similar components, rather than new performance studies.
§ 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.)