K232551 is an FDA 510(k) clearance for the EM-07 Cordless Endo Motor. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Forum Engineering Technologies (96) , Ltd. (Ashkelon, IL). The FDA issued a Cleared decision on July 9, 2024, 321 days after receiving the submission on August 23, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K232551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2023 |
| Decision Date | July 09, 2024 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |