K123582 is an FDA 510(k) clearance for the ENDO A CLASS. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Saeyang Microtech Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on August 16, 2013, 269 days after receiving the submission on November 20, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K123582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2012 |
| Decision Date | August 16, 2013 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |