Product code OAT

Device name

Implant, Endosseous, Orthodontic

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

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Source

FDA openFDA device classification dataset