FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
Device Facts
| Record ID | K072479 |
|---|---|
| Device Name | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD |
| Applicant | Rapid Injection Systems Corp. |
| Product Code | EBI · Dental |
| Decision Date | Nov 9, 2007 |
| 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.
