510(k) K243103
K243103 is an FDA 510(k) premarket notification submitted by Riton 3D Technology Co., Ltd. for the device "Denture Base". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2024
- Date Received
- September 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type