(255 days)
Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Not Found
This document is a 510(k) clearance letter for "Dentium Implantium® & SuperLine® Prosthetics." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets them.
The letter primarily focuses on:
- Confirming the substantial equivalence determination.
- Outlining regulatory compliance requirements for the manufacturer.
- Identifying the product code and classification.
- Stating the intended use of the device ("intended for use as an aid in prosthetic rehabilitation").
Therefore, I cannot provide the requested information based on the text provided. This type of regulatory document typically follows the completion of such studies, but does not detail the studies themselves.
§ 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.)