Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3080](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3080) → EHE — Dispenser, Mercury And/Or Alloy

# EHE · Dispenser, Mercury And/Or Alloy

_Dental · 21 CFR 872.3080 · Class 1_

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

## Overview

- **Product Code:** EHE
- **Device Name:** Dispenser, Mercury And/Or Alloy
- **Regulation:** [21 CFR 872.3080](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3080)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K771749](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHE/K771749.md) | AMALGAM DISPENSER | New Dimensions IN Medicine, Inc. | Sep 28, 1977 | SESE |
| [K771396](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHE/K771396.md) | DISPENSER, MERCURY & TABLET/POWDER | Johnson & Johnson Professionals, Inc. | Aug 3, 1977 | SESE |

## Top Applicants

- Johnson & Johnson Professionals, Inc. — 1 clearance
- New Dimensions IN Medicine, Inc. — 1 clearance

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

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