K140144 is an FDA 510(k) clearance for the BENDA WEDGE. This device is classified as a Handle, Instrument, Dental (Class I - General Controls, product code EJB).
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 8, 2014, 167 days after receiving the submission on January 22, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K140144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2014 |
| Decision Date | July 08, 2014 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJB — Handle, Instrument, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |