Cleared Traditional

K120956 - VSP SYSTEM

K120956 is an FDA 510(k) clearance for VSP SYSTEM, manufactured by Medical Modeling, Inc.. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K120956 · Medical Modeling, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
257d
Days
Class 2
Risk

K120956 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 Medical Modeling, Inc. (Washington, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 257 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 Medical Modeling, Inc. devices

FDA 510(k) Submission Details - K120956

510(k) Number K120956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date December 12, 2012
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 127d · This submission: 257d
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 24
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K120956.
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · KLS-Martin L.P. · Sep 2018
PROPEL Device
K172164 · Propel Orthodontics, LLC · Jan 2018
Dental Bone Cutting Instruments
K150796 · Synthes USA Products, LLC · Jun 2015
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K040369 · Stryker Instruments · Apr 2004
SURGICAL CUTTING BURS
K943540 · Stryker Corp. · Nov 1994
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
K915848 · Sensor Medics Corp. · Oct 1992