510(k) K230641
K230641 is an FDA 510(k) premarket notification submitted by Guilin Refine Medical Instrument Co., Ltd. for the device "Ultrasonic Scaler Tips". The FDA issued a decision of Substantially Equivalent on November 21, 2023. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Guilin Refine Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2023
- Date Received
- March 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type