← Product Code [NEA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA) · K011338

# OTO-CEM (K011338)

_Ototech, Inc. · NEA · Sep 13, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NEA/K011338

## Device Facts

- **Applicant:** Ototech, Inc.
- **Product Code:** [NEA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA.md)
- **Decision Date:** Sep 13, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **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/EN/subpart-d%E2%80%94prosthetic-devices/NEA/K011338](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NEA/K011338)

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