ALKALINER
Device Facts
| Record ID | K873882 |
|---|---|
| Device Name | ALKALINER |
| Applicant | Espe GmbH (Us) |
| Product Code | EJK · Dental |
| Decision Date | Feb 26, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.