KOOLINER II
Device Facts
| Record ID | K935261 |
|---|---|
| Device Name | KOOLINER II |
| Applicant | GC America, Inc. |
| Product Code | EBI · Dental |
| Decision Date | Jan 26, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3760 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.
