← Product Code [ELL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL) · K932012

# CAPS (K932012)

_Chemichl, Inc. · ELL · Nov 3, 1993 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K932012

## Device Facts

- **Applicant:** Chemichl, Inc.
- **Product Code:** [ELL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL.md)
- **Decision Date:** Nov 3, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3920
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K932012](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K932012)

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