← Product Code [EGD](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EGD) · K854530

# PREMIUM FLEXI-TOUGH (K854530)

_The Hygenic Corp. · EGD · Mar 4, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EGD/K854530

## Device Facts

- **Applicant:** The Hygenic Corp.
- **Product Code:** [EGD](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EGD.md)
- **Decision Date:** Mar 4, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6890
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EGD/K854530](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EGD/K854530)

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