CAVEX COLORCHANGE
Device Facts
| Record ID | K011419 |
|---|---|
| Device Name | CAVEX COLORCHANGE |
| Applicant | Cavex Holland BV |
| Product Code | ELW · Dental |
| Decision Date | Jul 16, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3660 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Special Controls
*Classification.* Class II (Special Controls).
