K062130 is an FDA 510(k) clearance for the MEISINGER BENEX, MODEL BE001. This device is classified as a Forceps, Tooth Extractor, Surgical (Class I - General Controls, product code EMG).
Submitted by Hager& Meisinger GmbH (Centennial, US). The FDA issued a Cleared decision on April 16, 2007, 264 days after receiving the submission on July 26, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K062130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2006 |
| Decision Date | April 16, 2007 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMG - Forceps, Tooth Extractor, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |