FDA product code PZY: Additively Manufactured, Preformed, Resin Denture Tooth
PZY is the FDA product code for additively manufactured, preformed, resin denture tooth. It is a Class II device, regulated under 21 CFR 872.3590 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under PZY. The average 510(k) review took 106 days (median 106).
Definition
For the fabrication of preformed denture teeth for use in a denture base
Classification
| Field | Value |
|---|---|
| Device name | Additively Manufactured, Preformed, Resin Denture Tooth |
| Device class | Class II |
| Regulation | 21 CFR 872.3590 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PZY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 106 |
Compare with all 510(k) review times · Search every PZY clearance
Top PZY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentca, Inc. | 1 | 2017-11-22 |
Most recent PZY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172398 | Dentca, Inc. | DENTCA DENTURE Teeth | 2017-11-22 | 106 |
Recalls for PZY devices
openFDA lists no recalls for product code PZY.
Frequently asked questions
What is FDA product code PZY?
PZY is the FDA product code for additively manufactured, preformed, resin denture tooth. It is a Class II device, regulated under 21 CFR 872.3590 and reviewed by the Dental panel.
What device class is PZY?
Class II, regulation 21 CFR 872.3590. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PZY?
Across 1 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most PZY clearances?
Dentca, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZY
- Run a recall and safety report across every PZY manufacturer
- Watch product code PZY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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