← Product Code [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS) · K852347

# DENTAL CASTING ALLOY GDC 1686 (K852347)

_Deringer-Ney, Inc. · EJS · Jul 31, 1985 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K852347

## Device Facts

- **Applicant:** Deringer-Ney, Inc.
- **Product Code:** [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS.md)
- **Decision Date:** Jul 31, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3060
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K852347](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K852347)

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