Product code ODU

Device name

Facial Implant

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.3500

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.

Source

FDA openFDA device classification dataset