K261826
- 510(k) number
- K261826
- Device name
- VSP System (Titanium Palatal Splint)
- Applicant
- 3D Systems, Inc. CO · US
- Product code
- DZJ — Driver, Wire, And Bone Drill, Manual
- Decision date
- 2026-06-03
- Date received
- 2026-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261826.pdf
Official FDA record: K261826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.