K201993 is an FDA 510(k) clearance for the E-connect S Endo Motor with built-in Apex Locator. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Changzhou Sifary Medical Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on January 29, 2021, 196 days after receiving the submission on July 17, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K201993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 196 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 |