DeviceClearance

Product code PZY— Dental

DENTCA DENTURE Teeth

Classification name
Additively Manufactured, Preformed, Resin Denture Tooth
Device class
Class 2
Regulation
21 CFR 872.3590
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PZY under 21 CFR 872.3590, via openFDA

Market context for product code PZY

FDA has cleared 1 device under product code PZY, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PZY

Recent clearances under product code PZY

Data sourced from openFDA. This site is unofficial and independent of the FDA.