← Product Code [EHP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP) · K800574

# VACUDENT LUMIX 65 (K800574)

_Vacudent Sales Corp. · EHP · May 20, 1980 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K800574

## Device Facts

- **Applicant:** Vacudent Sales Corp.
- **Product Code:** [EHP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP.md)
- **Decision Date:** May 20, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3285
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K800574](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EHP/K800574)

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