Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275) → MZW — Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

# MZW · Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

_Dental · 21 CFR 872.3275 · Class 2_

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

## Overview

- **Product Code:** MZW
- **Device Name:** Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
- **Regulation:** [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

## Classification Rationale

Zinc oxide-eugenol: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. Dental cement other than zinc oxide-eugenol: Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K073209](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/MZW/K073209.md) | MAXCEM 2 | Kerr Corporation | Jan 29, 2008 | SESE |
| [K991923](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/MZW/K991923.md) | SOOTHE-N-SEAL CANKER SORE RELIEF | Closure Medical Corp. | Sep 2, 1999 | SESE |

## Top Applicants

- Kerr Corporation — 1 clearance
- Closure Medical Corp. — 1 clearance

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

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