K082740 is an FDA 510(k) clearance for the GC AADVA ZR DISK. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on November 26, 2008, 69 days after receiving the submission on September 18, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K082740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2008 |
| Decision Date | November 26, 2008 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |