Cleared Traditional

VSP System (K192192) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192192 · 3D Systems · Dental device
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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

Submission Details

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.

Device Classification

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 19
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