← Product Code [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB) · K941066

# DENTAL 911 (K941066)

_L.A.F. Industries, Inc. · EMB · May 24, 1995 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K941066

## Device Facts

- **Applicant:** L.A.F. Industries, Inc.
- **Product Code:** [EMB](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB.md)
- **Decision Date:** May 24, 1995
- **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/K941066](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMB/K941066)

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