510(k) K242317
K242317 is an FDA 510(k) premarket notification submitted by Denjoy Dental Co., Ltd. for the device "Integrated Endo System (Meet Endo-II)". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- August 5, 2024
- 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