K082257 is an FDA 510(k) clearance for the ZENO AI ECO DISC. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on September 18, 2008, 41 days after receiving the submission on August 8, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K082257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2008 |
| Decision Date | September 18, 2008 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |