(a)Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
(b)Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)
(2) Class III (premarket approval). The device is classified as class III if it is a blade-form endosseous dental implant.
[69 FR 26304, May 12, 2004]