← Product Code [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB) · K821581

# DEN TEMP (K821581)

_Majestic Drug Co., Inc. · EMB · Jun 14, 1982 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K821581

## Device Facts

- **Applicant:** Majestic Drug Co., Inc.
- **Product Code:** [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB.md)
- **Decision Date:** Jun 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K821581](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K821581)

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