Cleared Traditional

K943540 - SURGICAL CUTTING BURS

K943540 is an FDA 510(k) clearance for SURGICAL CUTTING BURS, manufactured by Stryker Corp.. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K943540 · Stryker Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
131d
Days
Class 2
Risk

K943540 is an FDA 510(k) clearance for the SURGICAL CUTTING BURS. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 131 days - within the typical 510(k) review window.

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 Stryker Corp. devices

FDA 510(k) Submission Details - K943540

510(k) Number K943540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date November 30, 1994
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
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 27
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K943540.
VSP SYSTEM
K133907 · Medical Modeling, Inc. · Jan 2014
VSP SYSTEM
K120956 · Medical Modeling, Inc. · Dec 2012
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K040369 · Stryker Instruments · Apr 2004
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
K915848 · Sensor Medics Corp. · Oct 1992
TECHMEDICA I.B.O. BLADE
K883922 · Techmedica, Inc. · Dec 1988
DRILL, HAND, BONE, SMEDBERG
K871834 · Military Engineering, Inc. · Jul 1987