K-APATITE 20-40 MESH K-APATITE 40-60
Device Facts
| Record ID | K843557 |
|---|---|
| Device Name | K-APATITE 20-40 MESH K-APATITE 40-60 |
| Applicant | Katecho, Inc. |
| Product Code | ELE · Dental |
| Decision Date | Nov 30, 1984 |
| 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.
