← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K954192

# IMPREGUM PENTA (K954192)

_Espe GmbH & Co. Kg. · ELW · Dec 1, 1995 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K954192

## Device Facts

- **Applicant:** Espe GmbH & Co. Kg.
- **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md)
- **Decision Date:** Dec 1, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

## Special Controls

*Classification.* Class II (Special Controls).

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K954192](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K954192)

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