510(k) K261826
K261826 is an FDA 510(k) premarket notification submitted by 3D Systems, Inc. for the device "VSP System (Titanium Palatal Splint)". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. 3D Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2026
- Date Received
- June 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type