Cleared Traditional

K042394 - DIAGNODENT PERIO TIP (ACCESSORY)

K042394 is an FDA 510(k) clearance for DIAGNODENT PERIO TIP (ACCESSORY), manufactured by Kavo America Corporation. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K042394 · Kavo America Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
334d
Days
Class 2
Risk

K042394 is an FDA 510(k) clearance for the DIAGNODENT PERIO TIP (ACCESSORY). Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on August 2, 2005 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042394

510(k) Number K042394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2004
Decision Date August 02, 2005
Days to Decision 334 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
206d slower than avg
Panel avg: 128d · This submission: 334d
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 23
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K042394.
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
K051909 · Kavo America · Oct 2005
D-CARIE, MODEL N121-M1
K043156 · Neks Technologies, Inc. · Apr 2005
INSPEKTOR PRO
K040063 · Inspektor Dental Care BV · Jun 2004
KAVO DIAGNODENT
DEN990002 · Kavo America · Feb 2000
K042394 · DIAGNODENT PERIO TIP (ACCESSORY)
Download PDF FDA Summary Kavo America Corporat…