Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3430](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3430) → ETC — Mold, Middle-Ear

# ETC · Mold, Middle-Ear

_Ear, Nose, Throat · 21 CFR 874.3430 · Class 2_

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

## Overview

- **Product Code:** ETC
- **Device Name:** Mold, Middle-Ear
- **Regulation:** [21 CFR 874.3430](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3430)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921433](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC/K921433.md) | ATTIC DEFECT PLATE | Smith & Nephew Richards, Inc. | Mar 18, 1993 | SESE |

## Top Applicants

- Smith & Nephew Richards, Inc. — 1 clearance

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

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