MODIFIED GLUMA BONDING SYSTEM
Device Facts
| Record ID | K896382 |
|---|---|
| Device Name | MODIFIED GLUMA BONDING SYSTEM |
| Applicant | Heraeus Kulzer, Inc. |
| Product Code | KLE · Dental |
| Decision Date | Feb 1, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
