← Product Code [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB) · K862745

# EUGENOL USP (K862745)

_E&D Dental Manufacturing Co. · EMB · Jul 31, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K862745

## Device Facts

- **Applicant:** E&D Dental Manufacturing Co.
- **Product Code:** [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB.md)
- **Decision Date:** Jul 31, 1986
- **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/K862745](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K862745)

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