IMPRESSION TRAY
Device Facts
| Record ID | K780678 |
|---|---|
| Device Name | IMPRESSION TRAY |
| Applicant | Rocky Mountain Orthodontics, Inc. |
| Product Code | EHY · Dental |
| Decision Date | Apr 28, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6880 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.
