← Product Code [EJH](/productcode/EJH) · K853845

# ALLOY B (K853845)

_North American Alloys, Inc. · EJH · Nov 19, 1985 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K853845

## Device Facts

- **Applicant:** North American Alloys, Inc.
- **Product Code:** [EJH](/productcode/EJH.md)
- **Decision Date:** Nov 19, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3710
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.

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**Source:** [https://fda-staging.innolitics.com/device/K853845](https://fda-staging.innolitics.com/device/K853845)

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