← Product Code [EIH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH) · K001815

# DC ZIRKON (K001815)

_Austenal, Inc. · EIH · Aug 10, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K001815

## Device Facts

- **Applicant:** Austenal, Inc.
- **Product Code:** [EIH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH.md)
- **Decision Date:** Aug 10, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K001815](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K001815)

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