← Product Code [EBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBH) · K930487

# PALATRAY LC MINT (K930487)

_Heraeus Kulzer, Inc. · EBH · Jun 18, 1993 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBH/K930487

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [EBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBH.md)
- **Decision Date:** Jun 18, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3670
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of the patient's teeth and gums is made. The resin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from which a final, more precise, model of the patient's mouth is cast.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBH/K930487](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBH/K930487)

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