Cleared Traditional

K192192 - VSP System

K192192 is an FDA 510(k) clearance for VSP System, manufactured by 3D Systems. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K192192 · 3D Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
197d
Days
Class 2
Risk

K192192 is an FDA 510(k) clearance for the VSP System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on February 26, 2020 after a review of 197 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D Systems devices

FDA 510(k) Submission Details - K192192

510(k) Number K192192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZJ Device Classification - Class 2, Special Controls

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZJ Driver, Wire, And Bone Drill, Manual

All 23
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K192192.
DigiGuide System
K193499 · Protomed, Inc. · Nov 2020
MedCAD® AccuPlan® System
K192282 · Medcad · Oct 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · Immersivetouch · Jun 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · KLS-Martin L.P. · Mar 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · KLS-Martin L.P. · Sep 2018
PROPEL Device
K172164 · Propel Orthodontics, LLC · Jan 2018