# Additively Manufactured, Preformed, Resin Denture Tooth
> **Product code: PZY** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3590
## Classification
- **FDA Product Code:** PZY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.3590
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 45
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PZY)
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