← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K802491

# REIGNING REPAIR EPOXY RESIN (K802491)

_Oki Shiks USA , Ltd. · EBI · Nov 12, 1980 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K802491

## Device Facts

- **Applicant:** Oki Shiks USA , Ltd.
- **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md)
- **Decision Date:** Nov 12, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3760
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K802491](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K802491)

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