K962741 is an FDA 510(k) clearance for the TRI-PHASIX CHROMATIC ALGINATE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 6, 1996, 53 days after receiving the submission on July 15, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K962741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1996 |
| Decision Date | September 06, 1996 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |