Cleared Special

K060080 - DIAGNODENT 2190 WITH PERIODONTAL PROBE

K060080 is an FDA 510(k) clearance for DIAGNODENT 2190 WITH PERIODONTAL PROBE, manufactured by Kavo Dental Corporation. The device is a Class 2 Dental device with product code NTK cleared through the Special 510(k) pathway after a 29-day FDA review.

K060080 · Kavo Dental Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
29d
Days
Class 2
Risk

K060080 is an FDA 510(k) clearance for the DIAGNODENT 2190 WITH PERIODONTAL PROBE. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Kavo Dental Corporation (Deer Field, US). The FDA issued a Cleared decision on February 8, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060080

510(k) Number K060080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2006
Decision Date February 08, 2006
Days to Decision 29 days
Submission Type Special
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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

NTK Device Classification - Class 2, Special Controls

Product Code NTK Caries Detector, Laser Light, Transmission
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.

K060080 · DIAGNODENT 2190 WITH PERIODONTAL PROBE
Download PDF FDA Summary Kavo Dental Corporati…