SURGICAL VITEX
Device Facts
| Record ID | K862926 |
|---|---|
| Device Name | SURGICAL VITEX |
| Applicant | Jeneric Ind. |
| Product Code | ELE · Dental |
| Decision Date | Aug 29, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3645 |
| Device Class | Class 2 |
Regulatory Classification
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.
