Cleared Traditional

K943540 - SURGICAL CUTTING BURS (FDA 510(k) Clearance)

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

K943540 · Stryker Corp. · Dental device
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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

Submission Details

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
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.

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.