Cleared Traditional

K023367 - DETECTAR, MODEL N123-MI

K023367 is an FDA 510(k) clearance for DETECTAR, manufactured by Neks Technologies. The device is a Class 1 Dental device with product code EJB cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K023367 · Neks Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
260d
Days
Class 1
Risk

K023367 is an FDA 510(k) clearance for the DETECTAR, MODEL N123-MI. Classified as Handle, Instrument, Dental (product code EJB), Class I - General Controls.

Submitted by Neks Technologies (Chapel Hill, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 260 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Neks Technologies devices

FDA 510(k) Submission Details - K023367

510(k) Number K023367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date June 25, 2003
Days to Decision 260 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 127d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

EJB Device Classification - Class 1, General Controls

Product Code EJB Handle, Instrument, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.