510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023367Substantially Equivalent

Detectar, Model N123-Mi

Neks Technologies, Inc., Chapel Hill NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023367 is the FDA 510(k) clearance record for DETECTAR, MODEL N123-MI, a class I device, cleared for Neks Technologies on under FDA product code EJB (Handle, Instrument, Dental). FDA records list 3 510(k) clearances for Neks Technologies, from to . As of , FDA records show no recalls naming K023367.

Clearance record

Decision date
Received
(260 days to decision)
Product code
EJB Handle, Instrument, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Neks Technologies 103 Nolen Ln., Chapel Hill NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJB

Trailing 12 months

FDA records hold no clearances under product code EJB in the trailing twelve months.

FDA records show no clearances under product code EJB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260