Not Cleared Post-NSE

DEN990002 - KAVO DIAGNODENT (FDA 510(k) Clearance)

Class II Dental device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN990002 · Kavo America · Dental device
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Feb 2000
Decision
225d
Days
Class 2
Risk

DEN990002 is an FDA 510(k) submission (not cleared) for the KAVO DIAGNODENT. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Not Cleared (DENG) decision on February 22, 2000 after a review of 225 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Dental review framework.

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Submission Details

510(k) Number DEN990002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 12, 1999
Decision Date February 22, 2000
Days to Decision 225 days
Submission Type Post-NSE
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 127d · This submission: 225d
Pathway characteristics

Device Classification

Product Code NBL Laser, Fluorescence Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
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.