Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3590](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3590) → PZY — Additively Manufactured, Preformed, Resin Denture Tooth

# PZY · Additively Manufactured, Preformed, Resin Denture Tooth

_Dental · 21 CFR 872.3590 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PZY

## Overview

- **Product Code:** PZY
- **Device Name:** Additively Manufactured, Preformed, Resin Denture Tooth
- **Regulation:** [21 CFR 872.3590](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3590)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K172398](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PZY/K172398.md) | DENTCA DENTURE Teeth | Dentca, Inc. | Nov 22, 2017 | SESE |

## Top Applicants

- Dentca, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PZY](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PZY)

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