(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.)
[69 FR 26304, May 12, 2004]