Cleared Traditional

K063321 - D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138

K063321 is an FDA 510(k) clearance for D-CARIE/DETECTAR, manufactured by Neks Technologies, Inc.. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K063321 · Neks Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
148d
Days
Class 2
Risk

K063321 is an FDA 510(k) clearance for the D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Neks Technologies, Inc. (Laval, Quebec, CA). The FDA issued a Cleared decision on March 30, 2007 after a review of 148 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.

FDA 510(k) Submission Details - K063321

510(k) Number K063321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2006
Decision Date March 30, 2007
Days to Decision 148 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
20d slower than avg
Panel avg: 128d · This submission: 148d
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 K063321.
SOPROLIFE
K092583 · Sopro · Jan 2010
CARIESCAN PRO
K090598 · Cariescan , Ltd. · Dec 2009
SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
K090169 · Air Techniques, Inc. · Aug 2009
DIAGNODENT
K051909 · Kavo America · Oct 2005
DIAGNODENT PERIO TIP (ACCESSORY)
K042394 · Kavo America Corporation · Aug 2005
D-CARIE, MODEL N121-M1
K043156 · Neks Technologies, Inc. · Apr 2005
K063321 · D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
Download PDF FDA Summary Neks Technologies, In…