(29 days)
The Zimmer® Angled Contour Zirconia Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration in anterior and pre-molar regions.
The new Abutments have sa prepared margin and cone. The Abutments feature a pre-defined offset margin that is lower on the buccal aspect and higher on the lingual aspect to minimize the need to further prepare the Abutment by user. The cone portion of the Abutment is set at a 17 degree andle.
This document is a 510(k) premarket notification for a dental device, specifically the Zimmer® Angled Contour Zirconia Abutment. It details device modifications and its substantial equivalence to a predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, meaning the new device is as safe and effective as the predicate. It often relies on comparisons of design, materials, intended use, and performance data from internal testing to ensure the modified device functions similarly and poses no new risks. Without explicit performance criteria and a study demonstrating their achievement, it's impossible to fill in the requested table and answer the study-related questions.
Therefore, since the provided text does not contain the information requested, I cannot complete the table or answer the specific questions about acceptance criteria and 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.)