510(k) K232810
K232810 is an FDA 510(k) premarket notification submitted by Micro-Nx Co., Ltd. for the device "Dental Handpiece, Wireless Endodontic Handpiece, endoit". The FDA issued a decision of Substantially Equivalent on November 9, 2023. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Micro-Nx Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2023
- Date Received
- September 12, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type