PZY

Additively Manufactured, Preformed, Resin Denture Tooth

Product code

PZY

Device name

Additively Manufactured, Preformed, Resin Denture Tooth

Device class

Class 2

21 CFR

21 CFR 872.3590

Medical specialty

Dental

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).