PULPDENT CALCIUM HYDROXIDE PREPARATIONS
Device Facts
| Record ID | K944945 |
|---|---|
| Device Name | PULPDENT CALCIUM HYDROXIDE PREPARATIONS |
| Applicant | Pulpdent Corp. |
| Product Code | EJK · Dental |
| Decision Date | Nov 30, 1994 |
| 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.
