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) → EMB — Zinc Oxide Eugenol

# EMB · Zinc Oxide Eugenol

_Dental · 21 CFR 872.3275 · Class 1_

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

## Overview

- **Product Code:** EMB
- **Device Name:** Zinc Oxide Eugenol
- **Regulation:** [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K161630](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K161630.md) | Provicol QM Plus | Voco GmbH | Sep 15, 2016 | SESE |
| [K120695](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K120695.md) | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Dentist IN A Box Pty., Ltd. | Jun 12, 2012 | SESE |
| [K110759](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K110759.md) | TEMPOCEM | Dmg USA, Inc. | Jun 10, 2011 | SESE |
| [K073539](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K073539.md) | PROVISA CEM | Cavex Holland BV | Jan 31, 2008 | SESE |
| [K020158](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K020158.md) | NON-EUGENOL TEMPORARY CEMENT | J. Morita USA, Inc. | Mar 7, 2002 | SESE |
| [K941066](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K941066.md) | DENTAL 911 | L.A.F. Industries, Inc. | May 24, 1995 | SESE |
| [K861681](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K861681.md) | DENTIMEDIC DENTAL EMERGENCY KIT | Dentimedic | Sep 23, 1986 | SESE |
| [K862745](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K862745.md) | EUGENOL USP | E&D Dental Manufacturing Co. | Jul 31, 1986 | SESE |
| [K821581](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K821581.md) | DEN TEMP | Majestic Drug Co., Inc. | Jun 14, 1982 | SESE |
| [K801779](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K801779.md) | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Oxy Dental Products, Inc. | Aug 7, 1980 | SESE |
| [K772315](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K772315.md) | KWIKAP | Den-Mat Corp. | Jan 3, 1978 | SESE |

## Top Applicants

- Voco GmbH — 1 clearance
- Oxy Dental Products, Inc. — 1 clearance
- Majestic Drug Co., Inc. — 1 clearance
- L.A.F. Industries, Inc. — 1 clearance
- J. Morita USA, Inc. — 1 clearance

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

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