ESPE(R) -SIL
Device Facts
| Record ID | K913965 |
|---|---|
| Device Name | ESPE(R) -SIL |
| Applicant | Espe GmbH (Us) |
| Product Code | KLE · Dental |
| Decision Date | Dec 4, 1991 |
| 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.
