Product code PZY

Device name

Additively Manufactured, Preformed, Resin Denture Tooth

Medical specialty

Dental

Device class

2

Regulation number

872.3590

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For the fabrication of preformed denture teeth for use in a denture base

Source

FDA openFDA device classification dataset