Cleared Traditional

DETECTAR, MODEL N123-MI

K023367 · Neks Technologies · Dental

Jun 2003

Decision

260d

Days

Class 1

Risk

About This 510(k) Submission

K023367 is an FDA 510(k) clearance for the DETECTAR, MODEL N123-MI, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by Neks Technologies (Chapel Hill, US). The FDA issued a Cleared decision on June 25, 2003, 260 days after receiving the submission on October 8, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K023367 FDA.gov
FDA Decision	Cleared 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