K020898 is an FDA 510(k) clearance for the D.SIGN 15 (DW286 B). This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 29, 2002, 64 days after receiving the submission on January 24, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K020898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2002 |
| Decision Date | March 29, 2002 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3710 |