CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
Device Facts
| Record ID | K873689 |
|---|---|
| Device Name | CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL |
| Applicant | Dentsply Intl. |
| Product Code | GXP · Neurology |
| Decision Date | Oct 26, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.
