VSP System (Titanium Palatal Splint)— 510(k) K261826

Name: FDA 510(k) clearance K261826
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K261826 for VSP System (Titanium Palatal Splint), Substantially Equivalent on 2026-06-03. Applicant: 3D Systems, Inc.. Device class: 2.

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2026-06-01
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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