← Product Code [EHY](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHY) · K942668

# O-TRAY IMPRESSION TRAYS (K942668)

_Dentauraum, Inc. · EHY · Jul 22, 1994 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHY/K942668

## Device Facts

- **Applicant:** Dentauraum, Inc.
- **Product Code:** [EHY](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHY.md)
- **Decision Date:** Jul 22, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6880
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHY/K942668](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHY/K942668)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com