(133 days)
Thommen SPI® VARIOmulti Abutments are intended to be used in conjunction with SPT® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.
SPI® VARIOmulti Abutments are dental implant abutments for use with the SP1® Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit screw-retained, prefabricated restorations. The system includes dedicated prosthetic components. VARIOmulti Abutments are appropriate for supporting laboratory cast frameworks as well as machined titanium frameworks using the Nobel Biocare Procera® Implant Bridge Titanium.
The provided text is related to a 510(k) submission for a dental implant abutment (SPI® VARIOmulti Abutment). It focuses on administrative information, device description, and substantial equivalence to predicate devices, leading to FDA clearance.
Crucially, the provided document does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment. These elements are typically found in the scientific validation section of a 510(k) submission, which is not present in the given excerpt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is essentially a summary of the 510(k) clearance process and the device's intended use and classification.
To answer your questions, I would need a different part of the 510(k) submission that details the performance testing and validation results.
§ 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.)