Cleared Traditional

VSP System

K210347 · 3D Systems · Dental
Apr 2021
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K210347 is an FDA 510(k) clearance for the VSP System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on April 26, 2021, 77 days after receiving the submission on February 8, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K210347 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2021
Decision Date April 26, 2021
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120