K884418 is an FDA 510(k) clearance for the PREMIER DIE-TRAK ARTICULATOR. This device is classified as a Articulators (Class I - General Controls, product code EJP).
Submitted by Premier Medical (Philadelphia, US). The FDA issued a Cleared decision on November 14, 1988, 25 days after receiving the submission on October 20, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3150.
| 510(k) Number | K884418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1988 |
| Decision Date | November 14, 1988 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJP — Articulators |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3150 |