Product code NRQ

Device name

Blade-Form Endosseous Dental Implant

Medical specialty

Dental

Device class

2

Regulation number

872.3640

Review panel

DE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset