FDA.reportPublic FDA data

510(k) K261826

Device
VSP System (Titanium Palatal Splint)
Applicant
3D Systems, Inc.
510(k) number
K261826
Product code
DZJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-03
Date received
2026-06-01
Regulation
872.4120
Classification name
Driver, Wire, And Bone Drill, Manual
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Applicant Contact#

Contact
Archana Gopalan
Address
5381 S. Alkire Cir. Littleton CO US 80127 80127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K230276TECHFIT DISRP® SystemTechfit Digital Surgery2023-06-23
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K212570OsteoPlan SystemOsteomed, LLC2022-02-11
K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.2021-06-28
K193301coDiagnostiXDental Wings GmbH2021-06-21
K210347VSP System3D Systems2021-04-26
K193499DigiGuide SystemProtomed, Inc.2020-11-04
K192282MedCAD® AccuPlan® SystemMedcad2020-10-29
K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch2020-06-09
K192192VSP System3D Systems2020-02-26