Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3060](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3060) → EIT — Applicator, Rapid Wax, Dental

# EIT · Applicator, Rapid Wax, Dental

_Dental · 21 CFR 872.3060 · Class 2_

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

## Overview

- **Product Code:** EIT
- **Device Name:** Applicator, Rapid Wax, Dental
- **Regulation:** [21 CFR 872.3060](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3060)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

## Classification Rationale

Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

## Special Controls

*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K904467](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EIT/K904467.md) | ARGILITE 3 | Argen Precious Metals, Inc. | Oct 31, 1990 | SESE |

## Top Applicants

- Argen Precious Metals, Inc. — 1 clearance

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

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