K083701 is an FDA 510(k) clearance for the PANASIL INITIAL CONTACT AND PANASIL TRAY. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Kettenbach GmbH & Co. KG (Santa Barbara, US). The FDA issued a Cleared decision on January 9, 2009, 25 days after receiving the submission on December 15, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K083701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2008 |
| Decision Date | January 09, 2009 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |