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) → NEA — Cement, Ear, Nose And Throat

# NEA · Cement, Ear, Nose And Throat

_Dental · 21 CFR 872.3275 · Class 2_

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

## Overview

- **Product Code:** NEA
- **Device Name:** Cement, Ear, Nose And Throat
- **Regulation:** [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140644](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K140644.md) | PROCEM | Ototronix, LLC | Jun 19, 2014 | SESE |
| [K080032](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K080032.md) | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | Feb 28, 2008 | SESE |
| [K060750](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K060750.md) | STRYKER INJECTABLE CEMENT | Stryker Cmf | Apr 19, 2006 | SESE |
| [K042516](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K042516.md) | OTOMIMIX | Walter Lorenz Surgical, Inc. | Nov 8, 2004 | SESE |
| [K011338](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K011338.md) | OTO-CEM | Ototech, Inc. | Sep 13, 2001 | SESE |
| [K003567](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NEA/K003567.md) | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | Feb 12, 2001 | SESE |

## Top Applicants

- Walter Lorenz Surgical, Inc. — 1 clearance
- Stryker Cmf — 1 clearance
- Ototronix, LLC — 1 clearance
- Ototech, Inc. — 1 clearance
- Envoy Medical Corporation — 1 clearance

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

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