SR-IVOTRAY SPECIAL
Device Facts
| Record ID | K810524 |
|---|---|
| Device Name | SR-IVOTRAY SPECIAL |
| Applicant | J. Aderer, Inc. |
| Product Code | EHY · Dental |
| Decision Date | Mar 17, 1981 |
| 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.