Cleared Traditional

K051909 - DIAGNODENT

K051909 is an FDA 510(k) clearance for DIAGNODENT, manufactured by Kavo America. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K051909 · Kavo America · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
99d
Days
Class 2
Risk

K051909 is an FDA 510(k) clearance for the DIAGNODENT. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Kavo America (Deer Field, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 99 days - within the typical 510(k) review window.

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 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 Kavo America devices

FDA 510(k) Submission Details - K051909

510(k) Number K051909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date October 21, 2005
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NBL Laser, Fluorescence Caries Detection

All 20
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K051909.
SOPROLIFE
K092583 · Sopro · Jan 2010
SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
K090169 · Air Techniques, Inc. · Aug 2009
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
K063321 · Neks Technologies, Inc. · Mar 2007
DIAGNODENT PERIO TIP (ACCESSORY)
K042394 · Kavo America Corporation · Aug 2005
D-CARIE, MODEL N121-M1
K043156 · Neks Technologies, Inc. · Apr 2005
KAVO DIAGNODENT
DEN990002 · Kavo America · Feb 2000