K994077 is an FDA 510(k) clearance for the AROMA FINE (NORMAL AND FAST SET). This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 27, 2000, 56 days after receiving the submission on December 2, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K994077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1999 |
| Decision Date | January 27, 2000 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |