510(k) K242383
K242383 is an FDA 510(k) premarket notification submitted by Shenzhen Rogin Medical Co., Ltd. for the device "Apex Locator". The FDA issued a decision of Substantially Equivalent on March 7, 2025. The device falls under product code LQY (Locator, Root Apex), a Class U device. Shenzhen Rogin Medical Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2025
- Date Received
- August 12, 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