PREFORMED DENTAL IMPRESSION TRAYS
Device Facts
| Record ID | K850776 |
|---|---|
| Device Name | PREFORMED DENTAL IMPRESSION TRAYS |
| Applicant | L.A.K. Ent., Inc. |
| Product Code | EHY · Dental |
| Decision Date | Mar 18, 1985 |
| 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.
