510(k) K232551
K232551 is an FDA 510(k) premarket notification submitted by Forum Engineering Technologies (96) , Ltd. for the device "EM-07 Cordless Endo Motor". The FDA issued a decision of Substantially Equivalent on July 9, 2024. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Forum Engineering Technologies (96) , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2024
- Date Received
- August 23, 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