VSP System (Titanium Palatal Splint)
FDA 510(k) K261826 · 3D Systems, Inc.
510(k) numberK261826
Submission
- Device name
- VSP System (Titanium Palatal Splint)
- Applicant
- 3D Systems, Inc.
Littleton, CO, US - Received
- June 1, 2026
- Decision date
- June 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 04/04/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
| K210347 | VSP SystemDZJ · Traditional | 04/26/2021SE |
Questions and answers
When was VSP System (Titanium Palatal Splint) cleared by the FDA?
VSP System (Titanium Palatal Splint) (K261826) received a 510(k) decision of Substantially Equivalent on June 3, 2026, 2 days after the submission was received.
What is the product code of K261826?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.