← Product Code [ELE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE) · K862926

# SURGICAL VITEX (K862926)

_Jeneric Ind. · ELE · Aug 29, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K862926

## Device Facts

- **Applicant:** Jeneric Ind.
- **Product Code:** [ELE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE.md)
- **Decision Date:** Aug 29, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3645
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K862926](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K862926)

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