K011023 is an FDA 510(k) clearance for the D.SIGN 96. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).
Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on May 2, 2001, 28 days after receiving the submission on April 4, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K011023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2001 |
| Decision Date | May 02, 2001 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJT — Alloy, Gold-based Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |