EM-07 Cordless Endo Motor
FDA 510(k) K232551 · Forum Engineering Technologies (96) , Ltd.
510(k) numberK232551
Submission
- Device name
- EM-07 Cordless Endo Motor
- Applicant
- Forum Engineering Technologies (96) , Ltd.
Ashkelon, IL - Received
- August 23, 2023
- Decision date
- July 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoitEKX · Traditional | Micro-Nx Co., Ltd. | 11/09/2023SE |
More from Micro-Nx Co., Ltd.
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| K111474 | Bingo ProLQY · Traditional | 11/02/2011SE |
Questions and answers
When was EM-07 Cordless Endo Motor cleared by the FDA?
EM-07 Cordless Endo Motor (K232551) received a 510(k) decision of Substantially Equivalent on July 9, 2024, 321 days after the submission was received.
What is the product code of K232551?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.