510(k) K231990
K231990 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "Apex Locator". The FDA issued a decision of Substantially Equivalent on February 13, 2024. The device falls under product code LQY (Locator, Root Apex), a Class U device. Cefla S.C. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2024
- Date Received
- July 5, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type