510(k) K242765
K242765 is an FDA 510(k) premarket notification submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. for the device "Electronic Apex Locator (Alpha Apex I)". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code LQY (Locator, Root Apex), a Class U device. SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2025
- Date Received
- September 13, 2024
- 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