Cleared Traditional

VSP System

K192192 · 3D Systems · Dental
Feb 2020
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K192192 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 February 26, 2020, 197 days after receiving the submission on August 13, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K192192 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2019
Decision Date February 26, 2020
Days to Decision 197 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