K102984 is an FDA 510(k) clearance for the AURA. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on December 8, 2010, 62 days after receiving the submission on October 7, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K102984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2010 |
| Decision Date | December 08, 2010 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |