K111541 is an FDA 510(k) clearance for the ENDO-EXPRESS (R) HANDPIECE. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on March 16, 2012, 288 days after receiving the submission on June 2, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K111541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2011 |
| Decision Date | March 16, 2012 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGS - Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |