510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZYClass II

Additively Manufactured, Preformed, Resin Denture Tooth

21 CFR 872.3590 / Dental
FDA source (opens on fda.gov)

PZY is the FDA product code for Additively Manufactured, Preformed, Resin Denture Tooth, a class II device type, regulated under 21 CFR 872.3590. FDA's definition for this code reads: "For the fabrication of preformed denture teeth for use in a denture base". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PZY
Device name
Additively Manufactured, Preformed, Resin Denture Tooth
FDA definition
For the fabrication of preformed denture teeth for use in a denture base
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PZY

By decision year
1 clearance under product code PZY with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZY by decision year
YearClearances
20171

Applicants with the most clearances

Product code PZY
Applicants holding the most 510(k) clearances under product code PZY
ApplicantClearances
Dentca, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order