PREMIER DIE-TRAK ARTICULATOR
Device Facts
| Record ID | K884418 |
|---|---|
| Device Name | PREMIER DIE-TRAK ARTICULATOR |
| Applicant | Premier Medical |
| Product Code | EJP · Dental |
| Decision Date | Nov 14, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3150 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of the patient's jaws. An articulator is intended to fit dentures or provide orthodontic treatment.
