K092867 is an FDA 510(k) clearance for the IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT. 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 October 1, 2009, 13 days after receiving the submission on September 18, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K092867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2009 |
| Decision Date | October 01, 2009 |
| Days to Decision | 13 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 |