(14 days)
ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.
The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.
ALTATEC Camlog Implant System and Abutments
This document is a 510(k) clearance letter from the FDA for the ALTATEC Camlog Implant System and Abutments. It declares substantial equivalence to a predicate device, but does not contain information about acceptance criteria or a study proving the device meets them.
Therefore, I cannot extract the requested information from the provided document.
§ 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.)