K081120 is an FDA 510(k) clearance for the FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on May 1, 2008, 10 days after receiving the submission on April 21, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K081120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2008 |
| Decision Date | May 01, 2008 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |