PALATRAY LC MINT
Device Facts
| Record ID | K930487 |
|---|---|
| Device Name | PALATRAY LC MINT |
| Applicant | Heraeus Kulzer, Inc. |
| Product Code | EBH · Dental |
| Decision Date | Jun 18, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3670 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of the patient's teeth and gums is made. The resin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from which a final, more precise, model of the patient's mouth is cast.
