ULTRACAL XS
Device Facts
| Record ID | K970114 |
|---|---|
| Device Name | ULTRACAL XS |
| Applicant | Ultradent Products, Inc. |
| Product Code | EJK · Dental |
| Decision Date | Mar 14, 1997 |
| 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.
