Product code LYC

Device name

Bone Grafting Material, Synthetic

Medical specialty

Dental

Device class

2

Regulation number

872.3930

Review panel

DE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Source

FDA openFDA device classification dataset