K984365 is an FDA 510(k) clearance for the GC UNIFAST TRAD. This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 25, 1999, 80 days after receiving the submission on December 7, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K984365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1998 |
| Decision Date | February 25, 1999 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBI — Resin, Denture, Relining, Repairing, Rebasing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3760 |