Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3110](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3110) → DZS — Capsule, Dental, Amalgam

# DZS · Capsule, Dental, Amalgam

_Dental · 21 CFR 872.3110 · Class 1_

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

## Overview

- **Product Code:** DZS
- **Device Name:** Capsule, Dental, Amalgam
- **Regulation:** [21 CFR 872.3110](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3110)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K822610](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZS/K822610.md) | PRECAPSULED DENTAL AMALGAM | Syntex Dental Products, Inc. | Sep 14, 1982 | SESE |
| [K802967](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZS/K802967.md) | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- | Johnson & Johnson Professionals, Inc. | Dec 30, 1980 | SESE |
| [K781243](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZS/K781243.md) | MERCURY DISP. CAPSULE | Lee Pharmaceuticals | Sep 20, 1978 | SESE |
| [K780966](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZS/K780966.md) | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals | Aug 21, 1978 | SESE |

## Top Applicants

- Lee Pharmaceuticals — 2 clearances
- Syntex Dental Products, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance

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

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